Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard automated hematology analyzer and slidemaker stainer. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The studies focus on traditional analytical performance metrics like precision, linearity, and method comparison.

Therapeutic

No
The device is an in vitro diagnostic hematology analyzer used for screening and analysis of blood and body fluid samples, not for therapeutic purposes.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states "The UniCel DxH 900/DxH 690T Coulter Cellular Analysis System is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories."

SaMD (Software as a Medical Device)

No

The device description clearly indicates the system contains automated hematology analyzers (DxH 900 or DxH 690T) and a slidemaker stainer, which are physical hardware components used for sample processing and analysis.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "The UniCel DxH 900/DxH 690T Coulter Cellular Analysis System is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories."

The "Device Description" section also reiterates this: "The UniCel DxH 900/DxH 690T System contains an automated hematology analyzer (DxH 900 or DxH 690T) designed for in vitro diagnostic use in screening patient populations by clinical laboratories."

These statements clearly indicate that the device is intended to be used outside of the body to examine specimens (like blood and body fluids) for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The UniCel DxH 900/DxH 690T Coulter Cellular Analysis System is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The DxH 900/DxH 690T analyzer identifies and enumerates the following parameters:

· Whole Blood (Venous or Capillary): WBC, RBC, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO%, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF
· Pre-Diluted Whole Blood (Venous or Capillary): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV

· Body Fluids (cerebrospinal, serous or synovial): TNC and RBC

The UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

Product codes

GKZ

Device Description

The UniCel DxH 900/DxH 690T System contains an automated hematology analyzer (DxH 900 or DxH 690T) designed for in vitro diagnostic use in screening patient populations by clinical laboratories. The system provides a Complete Blood Count (CBC), Leukocyte 5-Part Differential (Diff), Reticulocyte (Retic), Nucleated Red Blood Cell (NRBC) on whole blood, as well as, Total Nucleated Count (TNC), and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).

The DxH Slidemaker Stainer II is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

The DxH 900 System may consist of a workcell (multiple connected DxH 900 instruments with or without a DxH Slidemaker Stainer II), a stand-alone DxH 900, or a stand-alone DxH Slidemaker Stainer II. The DxH 690T System consists of a stand-alone DxH 690T instrument.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adults (reference ranges for combined male and female, also separated for adult females and adult males)

Intended User / Care Setting

Clinical laboratories

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Flagging analysis:

Sample Size: A total of 735 residual normal (no flags, marked as negative) and abnormal (contained flags, marked as positive) whole blood samples.
Data Source: Three (3) clinical sites.
Annotation Protocol: Samples were tested and compared to the predicate device (DxH 800) based on CLSI H20-A2 guidelines. Results were classified into True Negative (TN), True Positive (TP), False Negative (FN), and False Positive (FP) categories.

Summary of Performance Studies

1. Specimen Sampling Positions Comparability Study:

Study Type: Comparability study.
Sample Size: Not explicitly stated, but implies a range of specimen types (whole blood, pre-diluted whole blood, body fluids).
Key Results: Comparability was tested on the DxH 800 (predicate) per EP09c, CLSI H26-A2, and CLSI H56. The shared hardware similarities between subject and predicate devices support the continued use of all specimen sampling positions for the intended use.

2. Repeatability Precision Study (Whole Blood and Body Fluid):

Study Type: Repeatability precision study.
Sample Size: Ten (10) aspirations of K2EDTA collected normal whole blood samples and body fluid specimens for within-run repeatability. Abnormal, low-level, and high-level samples (some contrived or control material) were also used to cover the analytical measuring interval.
Key Results: Testing performed on DxH 900-3S workcell (instruments BC03127, BC03129, and BC03130) according to CLSI H26-A2 and CLSI EP05-A3. Results for all parameters (WBC, RBC, Hgb, MCV, RDW, RDW-SD, Platelet, MPV, Neut%, Lymph%, Mono%, Eos%, Baso%, NRBC%, Retic%, IRF, MRV for whole blood; BF-RBC, BF-TNC for body fluids) passed their respective acceptance criteria for %CV or SD. Connection of instruments into a workcell configuration does not significantly impact precision.

3. Reproducibility Study:

Study Type: Reproducibility study.
Sample Size: Single lot of three (3) levels of 6C Plus, Retic-X, and Body Fluid cell controls. Analyzed 5 days, 2 different times/day, 3 shots per instrument for a total of 90 replicates per level.
Key Results: Tested on one (1) DxH900-3S workcell per CLSI EP05-A3. All test instruments met the reproducibility specifications for all parameters (WBC, RBC, HGB, MCV, RDW, RDW-SD, PLT, MPV, NE, LY, MO, EO, BA, NRBC for WB; RET; BF TNC, BF RBC for body fluids). Detailed tables showed SD and CV% for repeatability, between runs, between instrument, between days, and total reproducibility, all within acceptable ranges.

4. Linearity Study (Whole Blood and Body Fluid):

Study Type: Linearity study.
Sample Size: One (1) fresh whole blood sample (or surrogate cells) and one (1) body fluid sample concentrated to achieve high starting values. Dilutions prepared in 10% increments from 0% to 100%, with a minimum of seven (7) dilutions per series.
Key Results: Tested on the DxH 900-3S workcell (instruments BC03127, BC03129, BC03130) per CLSI EP06-A, 2nd Ed. Passed for all data points for WBC, RBC, PLT, HGB, BF-RBC, and BF-TNC across their respective analytical measuring intervals. Connection of instruments into a workcell configuration does not significantly impact linearity.
Linearity Ranges:
- WBC: 0.064 - 408.5 x10^3 cells/µL
- RBC: 0.001 - 8.560 x10^6 cells/µL
- PLT: 3.2 - 3002 x10^3 cells/µL
- HGB: 0.04 - 26.070 g/dL
- BF-RBC: 1113.10 - 6,353,906 cells/mm^3
- BF-TNC: 31.50 - 92,745 cells/mm^3

5. Carryover Study (Whole Blood and Body Fluid):

Study Type: High to Low Carryover study.
Sample Size: Not explicitly stated, involved replicate analysis of high and low target value tubes.
Key Results: Conducted on the DxH 900-3S workcell per CLSI H26-A2. No detectable carryover for whole blood or body fluids. Connection of instruments into a workcell configuration does not impact carryover.

6. Performance Detection Capability Limits Study (LoB, LLoD, LLoQ):

Study Type: Analytical sensitivity study.
Sample Size: 120 whole blood cassette presentation cycles and 120 single tube BF cycles for LoB. Four (4) samples per parameter (WBC, PLT, BF-RBC, BF-TNC) and three (3) sets of eleven (11) dilutions of stock solution (prepared in 10% increments) with five (5) replicates per dilution level per test instrument for LLoD/LLoQ.
Key Results: Conducted on the DxH 900-3S workcell per CLSI EP17-A2. LLoQ results for WBC (0.019 x10^3 cells/μL), PLT (0.757 x10^3 cells/μL), BF TNC (14.004 cells/mm^3), and BF RBC (979.869 cells/mm^3) met acceptance limits. These LLoQ values align with the background limit and lower limit of the analytical measuring interval. Connection of instruments into a workcell configuration does not significantly impact the analytical measuring range.

7. Reference Ranges Study (Adult):

Study Type: Reference interval verification study.
Sample Size: Not explicitly stated, implied to be sufficient for verifying reference intervals for male and female adults.
Key Results: Conducted on the DxH 900 per CLSI EP28-A3c. Verified that the reference intervals for male and female adults on the DxH 900/DxH 690T Analyzer are the same as the DxH 800 Analyzer. Connected workcells have the same reference ranges as a stand-alone instrument.

8. Whole Blood Method Comparison Study:

Study Type: Method comparison study (comparison to predicate DxH 800).
Sample Size: 734 samples for HCT, 733 for MCH/MCHC/RDW/RDWSD, 673 for NE/LY, 670 for MO, 647 for EO, 666 for BA, 726 for RETc, 616 for NRBCc, 734 for RBC/HGB/MCV, 687 for PLT/MPV, 681 for NE%/LY%, 678 for MO%, 655 for EO%, 674 for BA%, 727 for RETp, 723 for IRF, 727 for MRV, 723 for WBC, 619 for NRBC. (N varies per parameter)
Key Results: Tested according to EP09c & CLSI H26-A2. Compared CBC, NRBC, DIFF, and RETIC values between DxH 800 (predicate) and DxH 900 (subject). Data was comprehensive, covered the analytical measurement interval, and included samples from multiple sites and both stand-alone and connected workcell configurations using legacy and ECO reagents. Pooled data by general statistics (mean difference, 95% CI) and regression statistics (slope, intercept, correlation, 95% CI) showed substantial equivalence, with high correlation coefficients (e.g., 0.99960 for WBC, 0.99950 for HGB).

9. Body Fluid Method Comparison Study:

Study Type: Method comparison study (comparison to predicate DxH 800).
Sample Size: 130 samples for BF RBC, 195 samples for BF TNC.
Key Results: Tested according to EP09c, CLSI H26-A2, and CLSI H56. Compared BF-TNC and BF-RBC values between DxH 800 (predicate) and DxH 900 (subject). Data was comprehensive, covered the AMI, and from multiple sites including stand-alone and connected workcell configurations using legacy and ECO reagents. Pooled data by general statistics (mean difference, 95% CI) and regression statistics (slope, intercept, correlation, 95% CI) showed substantial equivalence, with high correlation coefficients (0.99991 for BF RBC, 0.99989 for BF TNC).

10. Flagging Analysis Study:

Study Type: Agreement study.
Sample Size: 735 residual normal and abnormal whole blood samples.
Key Metrics: Negative Percent Agreement (NPA), Positive Percent Agreement (PPA), Overall Percent Agreement (OPA).
Key Results: Compared flagging capabilities of DxH 900 to DxH 800 (predicate) using CLSI H20-A2 guidelines.
- Morphological Abnormalities (WB): NPA (0.9555, 95% CI: 0.9341 to 0.9702), PPA (0.8853, 95% CI: 0.8362 to 0.9211), OPA (0.9347, 95% CI: 0.9145 to 0.9504).
- Distributional Study (WB): NPA (0.8810, 95% CI: 0.8389 to 0.9131), PPA (0.9501, 95% CI: 0.9256 to 0.9668), OPA (0.9224, 95% CI: 0.9008 to 0.9397).
- Showed good clinical negative and positive percent agreement.

11. DxH 690T Performance Verification Testing:

Study Type: Performance verification.
Sample Size: One (1) DxH 690T, one (1) DxH 900, and one (1) DxH 800 (for accuracy).
Key Results: Tested daily checks, daily shutdown, calibration and initial control recovery, daily control recovery, repeatability, linearity, comparability (whole blood accuracy), and carryover. All test cases met predetermined acceptance criteria, demonstrating that analytical and clinical study data collected on a DxH 900 are representative of the DxH 690T.
- Repeatability (DxH 900 Automatic CDR Mode): All parameters passed.
- Repeatability (DxH 690T Automatic CDR Mode): All parameters passed.
- Linearity (DxH 900 & DxH 690T): LIN-X Linearity Control passed for all data points for WBC, RBC, Hgb, and PLT on both test instruments.
- Accuracy (Mean Difference/Bias Statistics vs DxH 800 predicate):
  - DxH 900 vs DxH 800: All parameters (WBC, RBC, Hgb, MCV, RDW, RDW-SD, PLT, MPV, Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil, RET, MRV, IRF) met DxH 800 accuracy specifications.
  - DxH 690T vs DxH 800: All parameters met DxH 800 accuracy specifications.
- Carryover (Within mode, automatic CDR): Carryover results for both DxH 690T and DxH 900 test instruments recovered within the DxH 800 carryover limits for WBC, RBC, Hgb, PLT, Diff, NRBC, and Retic at various high concentrations.

Key Metrics

Repeatability Results- Whole Blood CBC, DIFF, Retic:

WBC (5.000 - 10.000 x10^3 cells/µL): 0.69% CV
WBC (0.500 to 2.000 x10^3 cells/µL): 2.02% CV
RBC (4.500 - 5.500 x10^6 cells/µL): 0.50% CV
Hgb (14.00 - 16.00 g/dL): 0.36% CV
MCV (80.00 - 90.00 fL): 0.22% CV
RDW % (12.00 - 14.00 %): 1.31% CV
RDW-SD (33.00 - 48.00 fL): 1.82% CV
Platelet (200.0 - 400.0 x10^3 cells/µL): 1.35% CV
Platelet (10.0 to 15.0 x10^3 cells/µL): 2.60% CV
MPV (8.0 - 10.0 fL): 1.15% CV
Neut % (50.0 - 60.0 %): 0.99 %CV
Lymph % (25.0- 35.0 %): 2.44% CV
Mono % (5.0 - 10.0 %): 7.66 % CV
Eos % (2.0 - 5.0 %): 5.06% CV
Baso % (0.5 - 1.5 %): 0.13 SD
NRBC (1.00 - 2.00 %): 0.20 SD
NRBC (>2.00 - 15.00 %): 4.69% CV
NRBC (> 15.00 %): 5.12% CV
Retic % (0.000 - 1.500 %): 0.13 SD
Retic % (> 1.500 - 4.000 %): 0.09 SD
Retic % (> 4.000 - 15.000 %): 1.44% CV
IRF (≥ 0.20 N/A): 7.20%
MRV (100.0 - 120.0 fL): 1.19% CV

Repeatability Results for Body Fluids:

BF-RBC (10,000 - 15,000 cells/mm³): 2.42
BF-TNC (50-2,000 cells/mm³): 1.28

LLoQ Results:

WBC (x10^3 cells/μL): 0.019 (Acceptance limit ≤0.050)
PLT (x10^3 cells/μL): 0.757 (Acceptance limit ≤3.000)
BF TNC (cells/mm^3): 14.004 (Acceptance limit ≤20.000)
BF RBC (cells/mm^3): 979.869 (Acceptance limit ≤1000.000)

Flagging Study NPA, PPA, OPA:

Morphological Abnormalities for WB:
- NPA: 0.9555 (95% Confidence Limits: 0.9341 to 0.9702)
- PPA: 0.8853 (95% Confidence Limits: 0.8362 to 0.9211)
- OPA: 0.9347 (95% Confidence Limits: 0.9145 to 0.9504)
Distributional Study of WB:
- NPA: 0.8810 (95% Confidence Limits: 0.8389 to 0.9131)
- PPA: 0.9501 (95% Confidence Limits: 0.9256 to 0.9668)
- OPA: 0.9224 (95% Confidence Limits: 0.9008 to 0.9397)

Method Comparison (General Statistics for All Sites Combined):

Whole Blood (Difference between Test (DxH 900) and Reference (DxH 800) Means):
- HCT: -0.297
- MCH: 0.099
- MCHC: 0.236
- NE (10^3 cells/µL): 0.082
- LY (10^3 cells/µL): -0.020
- MO (10^3 cells/µL): 0.004
- EO (10^3 cells/µL): -0.005
- BA (10^3 cells/µL): 0.003
- RETc (10^6 cells/µL): 0.003
- NRBCc (10^3 cells/µL): 0.008
- RBC: -0.020
- HGB: -0.022
- MCV: -0.342
- RDW: -0.004
- RDWSD: -0.288
- PLT: -0.075
- MPV: 0.076
- NE %: 0.014
- LY %: 0.014
- MO %: -0.014
- EO %: -0.017
- BA %: 0.007
- RETp %: 0.075
- IRF: 0.002
- MRV: -1.115
- WBC (10^3 cells/µL): 0.055
- NRBC %: -0.005
Body Fluid (Difference between Test (DxH 900) and Reference (DxH 800) Means):
- BF RBC: 2601.802 cells/mm^3
- BF TNC: 50.878 cells/mm^3

Method Comparison (Regression Statistics and Correlation for All Sites Combined):

Whole Blood (Correlation Coefficient):
- HCT: 0.99860
- MCH: 0.99420
- MCHC: 0.95210
- NE (10^3 cells/µL): 0.99490
- LY (10^3 cells/µL): 0.99980
- MO (10^3 cells/µL): 0.99850
- EO (10^3 cells/µL): 0.84660
- BA (10^3 cells/µL): 0.68370
- RETc (10^6 cells/µL): 0.98720
- NRBCc (10^3 cells/µL): 0.99930
- RBC: 0.99920
- HGB: 0.99950
- MCV: 0.99780
- RDW: 0.99260
- RDWSD: 0.99400
- PLT: 0.99890
- MPV: 0.97770
- NE %: 0.99860
- LY %: 0.99840
- MO %: 0.99580
- EO %: 0.99310
- BA %: 0.81790
- RETp %: 0.99210
- IRF: 0.93350
- MRV: 0.97160
- WBC (10^3 cells/µL): 0.99960
- NRBC %: 0.99830
Body Fluid (Correlation Coefficient):
- BF RBC: 0.99991
- BF TNC: 0.99989

Predicate Device(s)

K193124, K162414

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract image of a human figure, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size than the rest of the text.

July 5, 2024

Beckman Coulter, Inc Marie Steigerwalt Staff Regulatory Affairs Specialist 11800 S.W. 147th Avenue Miami, Florida 33196

Re: K240252

Trade/Device Name: UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: June 3, 2024 Received: June 4, 2024

Dear Marie Steigerwalt:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by YAN CAI -S
YAN CAI -S Date: 2024.07.05 13:46:27
-04'00'

for

Min Wu Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

510(k) Number (if known) K240252

Device Name UniCel DxH 900 Coulter Cellular Analysis System ;

UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System

Indications for Use (Describe)

The UniCel DxH 900/DxH 690T Coulter Cellular Analysis System is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The DxH 900/DxH 690T analyzer identifies and enumerates the following parameters:

· Whole Blood (Venous or Capillary): WBC, RBC, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO%, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF · Pre-Diluted Whole Blood (Venous or Capillary): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV

· Body Fluids (cerebrospinal, serous or synovial): TNC and RBC

The UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K240252.

807.92 (a)(1): Contact Details

Name: Beckman Coulter, Inc Address: 11800 S.W. 147th Avenue Miami FL 33196 United States Phone: 305-380-3800 Email: msteigerwalt@beckman.com Contact: Marie Steigerwalt

807.92 (a)(2): Device Name

Trade Name:

UniCel DxH 900 Coulter Cellular Analysis System UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System UniCel DxH 690T Coulter Cellular Analysis System Common Name: Automated differential cell counter Classification Name: Counter, Differential Cell Regulation Number: 21 CFR 864.5220 Product Code(s): GKZ

807.92 (a)(3): Identification of the Legally Marketed Predicate Devices

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K193124	UniCel DxH 800 Coulter Cellular Analysis System with Early
Sepsis Indicator Application	GKZ
K162414	UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System	GKZ

807.92 (a)(4): Device Description Summary

The UniCel DxH 900/DxH 690T System contains an automated hematology analyzer (DxH 900 or DxH 690T) designed for in vitro diagnostic use in screening patient populations by clinical laboratories. The system provides a Complete Blood Count (CBC), Leukocyte 5-Part Differential (Diff), Reticulocyte (Retic), Nucleated Red Blood Cell (NRBC) on whole blood, as well as, Total Nucleated Count (TNC), and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).

The DxH Slidemaker Stainer II is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

The DxH 900 System may consist of a workcell (multiple connected DxH 900 instruments with or without a DxH Slidemaker Stainer II), a stand-alone DxH 900, or a stand-alone DxH Slidemaker Stainer II. The DxH 690T System consists of a stand-alone DxH 690T instrument. The available DxH 900 workcell systems are listed in the table below.

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DxH 900, DxH 690T and DxH Slidemaker Stainer II Stand-alone Instruments, and DxH 900 and DxH Slidemaker Stainer II Workcell Configurations

Configuration	Topologies			System Manager	Review Stations
DxH 900	DxH 900			Standard Computer	N/A
DxH 690T	DxH 690T			Standard Computer	N/A
DxH
Slidemaker
Stainer II	DxH Slidemaker Stainer II			Standard Computer	N/A
DxH 900 S	DxH Slidemaker Stainer II	DxH 900		Standard Computer	Optional Stand-alone
Review Station with
Standard Computer
DxH 900-2	DxH 900	DxH 900		Power Computer	Power Computer
DxH 900-2 S	DxH Slidemaker Stainer II	DxH 900	DxH 900	Power Computer	One Review Station
required with a
Power Computer.
Optional Review
Station with
Standard Computer
DxH 900-3	DxH 900	DxH 900	DxH 900	Power Computer	Two Review Stations
required, one with
Power Computer and
one with Standard
Computer
DxH 900-3 S	DxH Slidemaker Stainer II	DxH 900	DxH 900	DxH 900	Power Computer	Two Review Stations
required, one with
Power Computer and
one with Standard
Computer. Optional
Stand-alone
Workstation with
Standard Computer

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Principle of Operation:

The Coulter Principle is used to count and size cells by detecting and measuring changes in electrical resistance when a particle (such as a cell), in a conductive liquid, passes through a small aperture as shown in Figure 1.

Figure 1: Coulter Principle

Image /page/5/Figure/3 description: The image shows a diagram of a blood cell counter. The diagram includes labels for different parts of the counter, including the aperture current (1), vacuum (2), internal electrode (3), blood cell suspension (4), detail of aperture (5), aperture tube (6), aperture (7), sample beaker (8), and external electrode (9). The diagram provides a visual representation of the components and their arrangement within the blood cell counter.

Each cell, suspended in a conductive liquid (diluent), acts as an insulator. As each cell goes through the aperture, it momentarily increases the resistance of the electrical path between two submerged electrodes on either side of the aperture. This causes a measurable electronic pulse. For counting, the vacuum used to pull the diluted suspension of cells through the aperture must be at a regulated volume. While the number of pulses indicates particle count, the size of the electrical pulse is proportional to the cell volume.

The lytic reagent used for the WBC prepares the blood so the system can count leukocytes and measure the amount of hemoglobin. The lytic reagent rapidly and simultaneously destroys the erythrocytes and converts a substantial proportion of the hemoglobin to a stable pigment while it leaves leukocyte nuclei intact. The absorbance of the pigment is directly proportional to the hemoglobin concentration of the sample. Hemoglobin is measured photometrically at 525 nm using the sample from the WBC analysis. Clean diluent is introduced into the cuvette during each operating cycle and is used as a blank in the calculation of the HGB.

The COULTER VCS technology is used to determine the white cell differential, nucleated red blood cell and reticulocyte parameters along with associated flags, messages, histograms and

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data plots. As the particles pass through the sensing zone, a diode laser illuminates the particles. The flow cell measures volume, conductivity, multiple angles of light scatter, and axial light loss.

. For the WBC differential, sample preparation occurs at the Diff mix chamber where sample and reagents are added in the following order: Diff Lyse, blood, additional Diff Lyse followed by an air mix. Next, Diff preservative is added, followed by a second air mix, and an incubation period. The prepared sample is transferred to the module where cells are counted in an isometric sample stream. The algorithm analysis separates the WBC into five major populations.
. For NRBC, sample preparation occurs at the NRBC Diff mix chamber where sample and reagents are added in the following order: Diluent, blood, additional Diluent followed by an air mix. Next, DxH Cell Lyse is added, followed by a second air mix, and an incubation period. The prepared sample is transferred to the module where cells are counted in an isometric sample stream. The algorithm analysis separates NRBC from WBC.
Reticulocytes are immature, non-nucleated erythrocytes retaining a small network of . basophilic organelles, consisting of RNA and protoporphyrin. The enumeration of reticulocytes provides a simple, effective means to determine red cell production and regeneration. Reticulocyte immaturity is related to cell volume and light scatter. Since more immature reticulocytes are larger, contain more RNA and cause increased light scatter, the cell volume and light scatter will increase with immaturity of the cell.

The DxH Slidemaker Stainer II allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer II are moved to baskets for transfer to the Stainer portion by a robot. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient.

The aspiration probe aspirates the mixed sample, which is transported into the dispense probe. The probe moves to the drop placement position where blood is placed on the slide. A second slide is picked up and used to spread the drop on the first slide using the wedge technique. The prepared slide is transferred into the print shuttle where Information is thermally printed on the painted portion of the slide, and then into the basket elevator for drying. The dispense probe is cleaned in the dispense wash cup after drop placement on the slide.

For staining, the slide basket is dipped into each bath (1 to 5) for a staining time according to the active protocol. Each bath is configured to receive reagent from a predetermined supply source configured by the user. Slides are dried after staining.

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807.92 (a)(5): Intended Use

The UniCel DxH 900/DxH 690T Coulter Cellular Analysis System is a quantitative, multiparameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The DxH 900/DxH 690T analyzer identifies and enumerates the following parameters:

· Whole Blood (Venous or Capillary); WBC. RBC. HGB. HCT. MCV. MCH. MCHC. RDW. RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF

· Pre-Diluted Whole Blood (Venous or Capillary): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV

· Body Fluids (cerebrospinal, serous or synovial): TNC and RBC

The UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

807.92 (a)(5): Indications for Use Comparison

The UniCel DxH 900 Coulter Cellular Analysis System. UniCel DxH 690T Coulter Cellular Analysis System, and UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System are substantially equivalent to the UniCel DxH 800 Coulter Cellular Analysis System and UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System cleared under the 510(k) numbers K193124 and K162414. There are no changes to the intended use or claims.

807.92 (a)(6): Technological Comparison

The UniCel DxH 900 Coulter Cellular Analysis System. UniCel DxH 690T Coulter Cellular Analysis System, and UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System have the same technological characteristics (principal of operation, energy source, reagents, calibrators, controls, and packaging) as the predicate devices.

| Characteristic | Predicate DxH 800
K193124 | Subject DxH 900/690T System |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Analyzer:
The UniCel DxH 800 Coulter Cellular Analysis System
is a quantitative, multi-parameter, automated
hematology analyzer for in vitro diagnostic use in
screening patient populations found in clinical
laboratories.

The DxH 800 hematology analyzer identifies and
enumerates the following parameters:
• Whole Blood (Venous or Capillary): WBC, RBC,
HGB, HCT, MCV, MCH, MCHC, RDW, RDW-
SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%,
MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#,
RET%, RET#, MRV, IRF
• Pre-Diluted Whole Blood (Venous or Capillary):
WBC, RBC, HGB, HCT, MCV, MCH, MCHC,
RDW, RDW-SD, PLT, MPV | Same |
| Characteristic | Predicate DxH 800
K193124 | Subject DxH 900/690T System |
| | • Body Fluids (cerebrospinal, serous or synovial): TNC
and RBC | |
| Sampling Mechanism | Single aspiration probe used for all sampling.
Single tube presentation - open and closed vial
sampling - specimen manually mixed.
Automated presentation – closed vial sampling from
five-position cassette accepting a variety of defined
specimen tubes. Cassette containing specimens mixed
prior to starting sampling and between specimens.
Maximum initial load capacity 20 cassettes - System
will continuously process racks as added. | Same |
| Principles of
Measurement | WBC, RBC, MCV, PLT: Aperture impedance (Coulter®
Principle)
Hemoglobin: Spectrophotometric
WBC Differential, Reticulocytes, NRBC:
VCSn Technology using:
• Aperture impedance (DC)
• Conductivity (RF)
• Laser Light Scatter (Multiple angles)
• Laser Light Absorbance | Same |
| Consumables | Analysis Reagents
• COULTER DxH Diluent
• COULTER DxH Diff Pack
• COULTER DxH Cell Lyse
• COULTER DxH Retic Pack
• COULTER DxH Cleaner
Quality Control & Calibrators
• COULTER 6C Cell Control
• COULTER 6C Plus Cell Control
• COULTER Latron CP-X Control
• COULTER RETIC-X Cell Control
• COULTER LIN-X Control
• COULTER Body Fluids Control
• COULTER S-CAL Calibrator kit | Same, plus the option of the following
ECO reagents:
• DxH ECO Diluent (RTU)
• DxH Concentrated ECO
Diluent (18x)
• DxH ECO Cell Lyse |
| Pre-Analytic Features | | |
| System
configuration | PC based workstation running Microsoft Windows 7
application specific software Handheld Barcode Scanner
Printer | Same, but Windows 10 |
| Sampling
Mechanism | Single tube presentation - open and closed vial
sampling.
Automated presentation - closed vial sampling from 5
position cassette; Maximum initial load capacity 20
racks | Same |
| Mechanisms for
processing | Mechanisms to achieve process of:
Automated cassette transportation and specimen mixing
(by rocking), sample aspiration, sample preparation,
sample and reagent presentation to analytical modules,
sample analysis, raw data collection, algorithmic
processing and data reporting. | Same |
| Characteristic | Predicate DxH 800
K193124 | Subject DxH 900/690T System |
| | allowing multi-directional moves and capability to
return cassette to sampling position for repeat / reflex
testing. | |
| Sample Identification | Sample aspiration module (SAM) mounted barcode
reader for automated barcode reading of cassette
and sample tube identifiers. Manual barcode scanning of sample tube identifier
(handheld scanner) Manual keyboard entry of sample identifier | Same |
| Sample Processing | | |
| Aspiration Pathway | Single sampling probe and common aspiration pathway
used for all sample presentation modes. | Same |
| Sample Aspiration
Volume | Automatic, cap-piercing: 165 µL
Single tube - open-vial and cap pierce:165 µL
Pre-dilute 165 µL - fixed ratio of 1 in 5 dilution of blood
with diluent | Same |
| Throughput | For automatic mode:
CBC at 100 specimens/hr CBC and Differential at 100 specimens/hr CBC and Differential with NRBC at 90
specimens/hr Retic at 45 specimens/hr | Same |
| Data Reporting | Workstation display graphics, hardcopy printing and
transmission to Laboratory Information System (LIS) | Same |
| System Control and Software | | |
| System Software | System software (embedded and workstation) designed
specific to support all features of the DxH 800. The
software system consists of a Data Manager component,
a Universal System Manager component (including
algorithms), the User Interface, all of which are resident
in the system software in the workstation.
In addition, an Embedded Application is resident in the
analyzer. The Embedded application uploads from the
workstation on system power-up. Extensive real time
monitoring and reporting of system status including:
Component and module activities, System Voltages and Currents System Pressure and Vacuum System Temperatures Motor activity Mechanism Sensor status Reagent Pump Operation Raw data collection Single sampling probe and common aspiration pathway
used for all sample presentation modes. | Same system software with
enhancements to the instrument look
and feel, workflow, usability, quality
control and reliability. |
| Characteristic | Predicate DxH SMS
K162414 | Subject SMS II |
| Intended Use | The DxH Slidemaker Stainer is a fully automated slide
preparation and staining device that aspirates a whole-
blood sample, smears a blood film on a clean
microscope slide, and delivers a variety of fixatives,
stains, buffers, and rinse solutions to that blood smear. | Same |
| Characteristic | Predicate DxH 800
K193124 | Subject DxH 900/690T System |
| Specimen Collection | Whole venous blood in EDTA | Same |
| Blood Film
Preparation | Automatically prepared by DxH SMS | Same |
| Blood Film
Requirements | Section 6.3.1 of CLSI H20-A2 | Same |
| Consumables | Stains and Buffers: Beckman Coulter TruColor
Reagents for use on the DxH Slidemaker Stainer

• TruColor Wright Stain and TruColor Wright Buffer
• TruColor Wright-Giemsa Stain and TruColor Wright-Giemsa Buffer

Coulter TruColor Giemsa and May Grunwald Stains are
not validated by Beckman Coulter for use through
current default protocols on the system.

Fixative: Methanol is used as a fixative for whole-blood
smears in preparation for staining. Anhydrous methanol
(chromatography grade, 99.8% or higher quality) is
recommended.

Distilled Water: Distilled water is used to rinse the
stained smears before drying. CLSI Type CLRW water
is recommended. | Same |

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807.92 (b): Non-Clinical and/or Clinical Test Summary

a) Specimen Sampling Positions Comparability was tested on the DxH 800 (predicate) per EP09c, CLSI H26-A2, and CLSI H56 to establish equivalency for all sampling modes (Single tube open vial, Single tube closed vial, and Cassette presentations). Due to the similarities in the instrument hardware, data presented in K120771 continues to support the use of all specimen sampling positions as appropriate for the intended use of the device.

Test Panel	Reported Parameters	Specimen Type	Sampling Method
Complete Blood
Count (CBC)	• WBC, RBC, HGB, HCT, MCV,
MCH, MCHC, RDW, RDW-SD,
PLT, MPV	whole blood	• Automated cassette closed vial
• Manual single tube closed vial
• Manual single tube open vial
CBC and
Differential inc
NRBC
(CD)	• WBC, RBC, HGB, HCT, MCV,
MCH, MCHC, RDW, RDW-SD,
PLT, MPV
• NE%, NE#, LY%, ly#, MO%, MO#,
EO%, EO#, BA%, BA#, NRBC%,
and NRBC#	whole blood	• Automated cassette closed vial
• Manual single tube closed vial
• Manual single tube open vial
CBC, Differential
inc NRBC and
Retic
(CDR)	• WBC, RBC, HGB, HCT, MCV,
MCH, MCHC, RDW, RDW-SD,
PLT, MPV
• NE%, NE#, LY%, ly#, MO%, MO#, MO#,
EO%, EO#, BA%, BA#, NRBC%,
and NRBC#
• RET%, RET#, MRVM IRF	whole blood	• Automated cassette closed vial
• Manual single tube closed vial
• Manual single tube open vial
CBC and Retic
(CR)	• WBC, RBC, HGB, HCT, MCV,
MCH, MCHC, RDW, RDW-SD,
PLT, MPV
• RET%, RET#, MRVM IRF	whole blood	• Automated cassette closed vial
• Manual single tube closed vial
• Manual single tube open vial
Retic
(R)	• RET%, RET#, MRVM IRF	whole blood	• Automated cassette closed vial
• Manual single tube closed vial
• Manual single tube open vial

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Test Panel	Reported Parameters	Specimen Type
Pre-dilute
(PreDilx5)	• WBC, RBC, HGB, HCT, MCV,
MCH, MCHC, RDW, RDW-SD,
PLT, MPV	1 in 5 pre-diluted
whole blood	• Manual single tube open vial
Body Fluid
(BF)	• TNC, RBC	body fluid
(cerebrospinal, serous
and synovial)	• Manual single tube open vial

b) Whole blood and body fluid repeatability precision was tested on the DxH 900-3S workcell (instruments BC03127, BC03129, and BC03130) using the instrument's repeatability mode using cassette presentation for whole blood and single-tube presentation sampling for body fluids. Testing was performed according to CLSI H26-A2 and CLSI EP05-A3 to demonstrate the precision of the DxH 900 using whole blood and body fluid specimens. The whole blood and body fluid precision data provided supports the precision claims in the instructions for use. Connection of instruments into a workcell configuration does not significantly impact the precision.
Within run Repeatability of the parameters was performed using ten (10) aspirations of normal whole blood samples collected in K2EDTA. Specimens were selected for testing based on parameter value within specific ranges per parameter (measurand) to cover across the analytical measuring interval (AMI). Within run Imprecision (repeatability) was tested by performing replicate analysis of the specimens selected using the Repeatability function. Targeted specimens were used for more than one measurand. The coverage of the other measurand's measuring ranges was dependent on the spread of the samples collected to cover the measuring interval of the measurands. If normal and clinical specimens in the intended use populations were not found for estimation of precision profiles, contrived samples and control material were used.

Abnormal patient samples with low NRBC (1.00 - 2.00, >2.00 - 15.00), high NRBC (>15.00), and high Reticulocytes (>4.000 - 15.0) were not available during the test period. Instead, control material was used to assess Repeatability for these parameter values. Also, low levels for WBC 0.500 - 2.000 x103 cells/uL, Platelet 10.0 - 15.0 x103 cells/μL, Body fluid RBC 10,000 - 15,000 cells/mm3 and TNC 50-2,000 cells/mm3 were performed using altered whole blood samples due to no donor availability during the testing period as well.

| Parameter | Units | Level | N | Test Result Mean | Test Result %CV or
SD | Acceptance |
|-----------|---------------|----------------|----|------------------|--------------------------|------------|
| WBC | x103 cells/µL | 5.000 - 10.000 | 10 | 5.80 | 0.69% CV | Pass |
| WBC | x103 cells/µL | 0.500 to 2.000 | 10 | 0.59 | 2.02% CV | Pass |
| RBC | x106 cells/µL | 4.500 - 5.500 | 10 | 4.72 | 0.50% CV | Pass |
| Hgb | g/dL | 14.00 - 16.00 | 10 | 15.03 | 0.36% CV | Pass |
| MCV | fL | 80.00 - 90.00 | 10 | 85.39 | 0.22% CV | Pass |
| RDW % | % | 12.00 - 14.00 | 10 | 13.71 | 1.31% CV | Pass |
| RDW-SD | fL | 33.00 - 48.00 | 10 | 47.03 | 1.82% CV | Pass |
| Platelet | x103 cells/µL | 200.0 - 400.0 | 10 | 256.80 | 1.35% CV | Pass |
| Platelet | x103 cells/µL | 10.0 to 15.0 | 10 | 12.90 | 2.60% CV | Pass |
| MPV | fL | 8.0 - 10.0 | 10 | 8.13 | 1.15% CV | Pass |
| Neut % | % | 50.0 - 60.0 | 10 | 58.24 | 0.99 %CV | Pass |
| Lymph % | % | 25.0- 35.0 | 10 | 26.34 | 2.44% CV | Pass |
| Mono % | % | 5.0 - 10.0 | 10 | 6.22 | 7.66 % CV | Pass |

Repeatability Results- Whole Blood CBC, DIFF, Retic

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Parameter	Units	Level	N	Test Result Mean	Test Result %CV or SD	Acceptance
Eos %	%	2.0 - 5.0	10	2.21	5.06% CV	Pass
Baso %	%	0.5 - 1.5	10	1.22	0.13 SD	Pass
NRBC	%	1.00 - 2.00	10*	1.46	0.20 SD	Pass
NRBC	%	>2.00 - 15.00	10*	9.21	4.69% CV	Pass
NRBC	%	> 15.00	10*	19.12	5.12% CV	Pass
Retic %	%	0.000 - 1.500	10	1.17	0.13 SD	Pass
Retic %	%	> 1.500 - 4.000	10	1.52	0.09 SD	Pass
Retic %	%	> 4.000 - 15.000	10*	10.07	1.44% CV	Pass
IRF	N/A	≥ 0.20	10	0.47	7.20%	Pass
MRV	fL	100.0 - 120.0	10	118.40	1.19% CV	Pass

*Control Material was used

Repeatability Results for Body Fluids

| Parameter | Units | Level | N | Test Result
Mean | Test Result %CV
or SD | Acceptance |
|-----------|-----------|-----------------|----|---------------------|--------------------------|------------|
| BF-RBC | cells/mm³ | 10,000 - 15,000 | 10 | 12,643 | 2.42 | Pass |
| BF-TNC | cells/mm³ | 50-2,000 | 10 | 594 | 1.28 | Pass |

c) Reproducibility testing was performed on the DxH 900-3S workcell using a single lot of all three (3) levels of 6C Plus, Retic-X, and Body Fluid cell controls. The table below shows the control material used for each material.

Control Material Used	Parameter
COULTER 6C PLUS Cell Control
(3 levels)	WBC
	RBC
	HGB
	MCV
	RDW
	RDW-SD
	PLT
	MPV
	NE
	LY
	MO
	EO
	BA
	NRBC
COULTER RETIC-X Cell Control
(3 levels)	RET

COULTER Body Fluids Control
(3 levels)	BF TNC
	BF RBC

The controls were analyzed on one (1) DxH900-3S workcell, five (5) days, two (2) different times on the same day and three (3) shots per instrument, two (2) hours apart, per CLSI EP05-A3. The test instruments met the reproducibility specifications for all parameters.

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| | | Mean | Repeatability |-------|-------------|--- | Level | Parameter | Unit | | WBC | | RBC | | HGB | g/dL | | MCV | Fl | | RDW | % | | RDW-SD | ਸ | | PLT | | MPV | fL | Level | NE | % | l | LY | % | | MO | % | | EO | % | | BA | % | | NRBC | % | | RET | % | | BF TNC | | BF RBC | | WBC | | RBC | | HGB | g/dL | | MCV | Fl | | RDW | % | | RDW-SD | fL | | PLT | Level | MPV | fL | 2 | NE | % | | LY | % | | MO | % | | EO | % | | BA | % | | NRBC | % | | RET | 0% | | BF TNC | | BF RBC | | WBC | | RBC | | HGB | g/dL | | MCV | F1 | | RDW | % | | RDW-SD | fL | | PLT | Level | MPV | fL | 3 | NE | %
% | 90 | 57.05 | | LY | % 90 | 27.73 0.00 | 0.00 0.00 | 0.00
0.00 | 0.59 | 2.13 | | MO | % | | EO | % 90 | 6.82 0.02 | 6.86
54.51 | 0.00
0.01 | 0.00
13.07 | 0.00
0.00 | 0.00
9.39 | 0.00 | 0.00
0.00 | 0.47
0.02 | 6.86 |
| | BA | % | | NRBC
RET | % | 90 10.50 | 0.52
0.18 | 1.72 | 0.00 0.00 | 0.49
0.11 | | 0.07 2.14 |
| | BF TNC 1.16 | 0.00 | 0.00 | | BF RBC | N
| | Between Runs | | Between Instrument | | Between Days | | Reproducibility | | |
------------|-----------|------------------------|--------------|---------------|--------------|--------------------|--------------|--------------|--------------|-----------------|--------------|--------------|
| | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 10^3 cells/uL | 90 | 3.42 | 0.07 | 1.90 | 0.00 | 0.00 | 0.04 | 1.26 | 0.01 | 0.27 | 0.08 | 2.30 |
| 10^6 cells/uL | 90 | 1.74 | 0.01 | 0.59 | 0.00 | 0.11 | 0.00 | 0.26 | 0.00 | 0.00 | 0.01 | 0.66 |
| 90 | 4.62 | 0.02 | 0.43 | 0.00 | 0.00 | 0.01 | 0.26 | 0.01 | 0.13 | 0.02 | 0.52 |
| 90 | 79.48 | 0.14 | 0.18 | 0.19 | 0.24 | 0.23 | 0.29 | 0.19 | 0.24 | 0.38 | 0.48 |
| 90 | 17.09 | 0.15 | 0.89 | 0.14 | 0.82 | 0.08 | 0.44 | 0.00 | 0.03 | 0.22 | 1.28 |
| 90 | 49.50 | 0.49 | 1.00 | 0.19 | 0.38 | 0.10 | 0.21 | 0.10 | 0.20 | 0.55 | 1.11 |
| 10^3 cells/uL | 90 | 72.39 | 1.11 | 1.53 | 0.00 | 0.00 | 0.28 | 0.39 | 0.33 | 0.45 | 1.19 | 1.64 |
| 90 | 9.13 | 0.06 | 0.66 | 0.00 | 0.00 | 0.03 | 0.30 | 0.03 | 0.34 | 0.07 | 0.80 |
| 90 | 43.13 | 0.69 | 1.61 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.69 | 1.61 |
| 90 | 46.24 | 0.72 | 1.56 | 0.00 | 0.00 | 0.12 | 0.25 | 0.00 | 0.00 | 0.73 | 1.58 |
| 90 | 6.67 | 0.40 | ર તેર | 0.00 | 0.00 | 0.15 | 2.29 | 0.00 | 0.00 | 0.43 | 6.38 |
| 90 | 3.94 | 0.34 | 8.58 | 0.14 | 3.67 | 0.00 | 0.00 | 0.00 | 0.00 | 0.37 | 9.33 |
| 90 | 0.02 | 0.02 | 74.92 | 0.00 | 0.00 | 0.00 | 0.00 | 0.01 | 26.29 | 0.02 | 79.39 |
| 90 | 0.29 | 0.10 | 34.20 | 0.00 | 0.00 | 0.05 | 15.62 | 0.00 | 0.00 | 0.11 | 37.60 |
| 90 | 0.87 | 0.10 | 11.18 | 0.02 | 2.71 | 0.15 | 17.41 | 0.00 | 0.00 | 0.18 | 20.86 |
| cells/mm^3 | 90 | 120.74 | 6.51 | 5.39 | 3.63 | 3.01 | 3.41 | 2.83 | 3.18 | 2.64 | 8.79 | 7.28 |
| cells/mm^3 | 90 | 12204.83 | 398.75 | 3.27 | 0.00 | 0.00 | 276.21 | 2.26 | 0.00 | 0.00 | 485.07 | 3.97 |
| 10^3 cells/uL | 90 | 20.52 | 0.17 | 0.83 | 0.11 | 0.53 | 0.24 | 1.16 | 0.06 | 0.28 | 0.32 | ાં રેડ |
| 10^6 cells/uL | 90 | 3.96 | 0.03 | 0.74 | 0.02 | 0.45 | 0.02 | 0.49 | 0.01 | 0.22 | 0.04 | 1.02 |
| 90 | 11.80 | 0.05 | 0.45 | 0.02 | 0.18 | 0.07 | 0.61 | 0.01 | 0.11 | 0.09 | 0.79 |
| 90 | 87.38 | 0.19 | 0.22 | 0.05 | 0.05 | 0.25 | 0.29 | 0.15 | 0.17 | 0.35 | 0.40 |
| 90 | 16.24 | 0.16 | 1.01 | 0.06 | 0.37 | 0.01 | 0.09 | 0.08 | 0.51 | 0.19 | 1.19 |
| 90 | 52.73 | 0.67 | 1.27 | 0.14 | 0.26 | 0.08 | 0.14 | 0.17 | 0.32 | 0.71 | 1.35 |
| 10^3 cells/uL | 90 | 424.58 | 7.98 | 1.88 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 7.98 | 1.88 |
| 90 | 9.44 | 0.06 | 0.58 | 0.00 | 0.00 | 0.05 | 0.54 | 0.02 | 0.18 | 0.08 | 0.82 |
| 90 | 65.12 | 0.68 | 1.05 | 0.00 | 0.00 | 0.00 | 0.00 | 0.12 | 0.19 | 0.69 | 1.07 |
| 90 | 15.71 | 0.50 | 3.21 | 0.07 | 0.46 | 0.13 | 0.80 | 0.09 | 0.60 | 0.53 | 3.39 |
| 90 | 14.16 | 0.52 | 3.65 | 0.26 | 1.84 | 0.00 | 0.00 | 0.00 | 0.00 | 0.58 | 4.09 |
| 90 | 4.96 | 0.41 | 8.33 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.41 | 8.33 |
| 90 | 0.06 | 0.03 | 57.53 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.03 | 57.53 |
| 90 | 9.09 | 0.40 | 4.36 | 0.07 | 0.78 | 0.00 | 0.00 | 0.08 | 0.90 | 0.41 | 4.53 |
| 90 | 2.48 | 0.12 | 4.73 | 0.00 | 0.00 | 0.16 | 6.50 | 0.04 | 1.78 | 0.20 | 8.23 |
| cells/mm^3 | 90 | 1526.92 | 20.38 | 1.33 | 4.95 | 0.32 | 11.01 | 0.72 | 12.20 | 0.80 | 26.64 | 1.74 |
| cells/mm^3 | 90 | 1681333.92 | 8753.35 | 0.52 | 4306.83 | 0.26 | 16235.20 | 0.97 | 963.34 | 0.06 | 18965.22 | 1.13 |
| 10^3 cells/uL | 90 | 8.58 | 0.10 | 1.20 | 0.00 | 0.00 | 0.04 | 0.47 | 0.03 | 0.40 | 0.12 | 1.35 |
| 10^6 cells/uL | 90 | 5.28 | 0.03 | 0.62 | 0.02 | 0.33 | 0.04 | 0.77 | 0.01 | 0.24 | 0.06 | 1.07 |
| 90 | 15.61 | 0.09 | 0.59 | 0.00 | 0.00 | 0.14 | 0.89 | 0.04 | 0.29 | 0.17 | 1.10 |
| 90 | 87.59 | 0.22 | 0.26 | 0.00 | 0.00 | 0.24 | 0.28 | 0.14 | 0.16 | 0.36 | 0.41 |
| 90 | 15.47 | 0.17 | 1.09 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.17 | 1.09 |
| 90 | 50.86 | 0.60 | 1.19 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.60 | 1.19 |
| 10^3 cells/uL | 90 | 222.27 | 3.16 | 1.42 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 3.16 | 1.42 |
| 90 | 9.61 | 0.06 | 0.67 | 0.02 | 0.26 | 0.04 | 0.46 | 0.00 | 0.00 | 0.08 | 0.85 |
| 0.81 | 1.42 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.81 | 1.42 |
| 90
| 0.59 | 2.13 | 0.00 | 0.00
| 0.00 | 0.00
|
| | 8.36 | 0.40 | 4.78 | 0.00 | | 0.00 | 0.00 | 0.00 | | 0.40 | 4.78 |
| 90
| 0.47
| 90 | 0.04 | | 2.66 | 0.00 | | | 2.52 | 0.09 | 0.45 | 0.72 | 56.83 |
| 19.45
| 0.00
| 0.69 | 0.23 | 3.69
| cells/mm^3 | 90 | 65778.99 | 514.83 | 0.78 | 265.68 | 0.40 | 763.00 | 1.09
| 958.02 | 1.46 |
| cells/mm^3 | | 90 5639354.09 50090.17 | | 0.89 | 0.00 | 0.00 | 32100.78 | 0.57 | 1922.28 | 0.03 | 59524.62 | 1.06 |

Analysis for Instrument Combined

14

Parameter	Unit	N	Mean	SD	CV%
BF RBC	cells/mm^3	11	73724	851	1.1
	cells/mm^3	10	74706	1166	1.5
	cells/mm^3	9	12624	407	3.2
BF-TNC	cells/mm^3	10	309	9	3.1
	cells/mm^3	11	1270	21	1.7
	cells/mm^3	12	696	20	3.0
	cells/mm^3	10	3070	65	2.1
	cells/mm^3	10	24879	207	0.83
	cells/mm^3	9	1281	26	2.0
	cells/mm^3	10	214	10	4.9

Additional Body Fluid Precision Runs

d) Linearity: Whole Blood and Body Fluid Linearity was tested on the DxH 900-3S workcell per CLSI EP06-A, 2nd Ed to assess system linearity of whole blood count parameters (WBC, RBC, PLT and HGB) and Body Fluids parameters (BF-RBC and BF-TNC) across the analytical measuring interval (AMI). Fresh whole blood was obtained and concentrated to achieve a high starting value near the upper limit of the AMI for each measurand. If values near the upper limit were not achieved using whole blood, surrogate (analog) cells were used instead. Dilutions were prepared of each measurand to cover the AMI and tested in quadruplicate in random order. Each dilution series contained a minimum of seven (7) dilutions and testing was performed on three (3) instruments. For count measurands, given the wide measuring interval, additional dilutions at the low end of the range were required.

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0.012 | 0.049 | 0.070 | 0.081 | -0.01092 | -13.44 | 0.100 | Pass |
| 0.024 | 0.098 | 0.128 | 0.131 | -0.00217 | -1.66 | 0.100 | Pass |
| 0.049 | 0.200 | 0.237 | 0.233 | 0.00389 | 1.67 | 0.100 | Pass |
| 0.098 | 0.400 | 0.460 | 0.434 | 0.02613 | 6.02 | 0.100 | Pass |
| 0.195 | 0.797 | 0.864 | 0.832 | 0.03136 | 3.77 | 0.100 | Pass |
| 0.391 | 1.597 | 1.738 | 1.637 | 0.10097 | 6.17 | 0.174 | Pass |
| 0.781 | 3.191 | 3.371 | 3.237 | 0.13337 | 4.12 | 0.200 | Pass |
| 1.563 | 6.385 | 6.466 | 6.447 | 0.01965 | 0.30 | 0.200 | Pass |
| 3.125 | 12.767 | 13.191 | 12.857 | 0.33375 | 2.60 | 0.396 | Pass |
| 6.25 | 25.534 | 26.338 | 25.682 | 0.65550 | 2.55 | 0.790 | Pass |
| 12.5 | 51.068 | 51.626 | 51.333 | 0.29268 | 0.57 | 1.549 | Pass |
| 25 | 102.135 | 103.036 | 102.634 | 0.40170 | 0.39 | 5.152 | Pass |
| 50 | 204.271 | 204.357 | 205.236 | -0.87860 | -0.43 | 10.218 | Pass |
| 100 | 408.541 | 408.541 | 410.440 | -1.89885 | -0.46 | 20.427 | Pass |

Deviation from Linearity for WBC 10^3/μL on Instrument BC03127

Deviation from Linearity for WBC 10^3/µL on Instrument BC03129

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0.012 | 0.051 | 0.065 | 0.075 | -0.00995 | -13.33 | 0.100 | Pass |
| 0.024 | 0.101 | 0.125 | 0.126 | -0.00057 | -0.45 | 0.100 | Pass |
| 0.049 | 0.207 | 0.240 | 0.232 | 0.00828 | 3.57 | 0.100 | Pass |
| 0.098 | 0.414 | 0.452 | 0.440 | 0.01255 | 2.85 | 0.100 | Pass |
| 0.195 | 0.824 | 0.882 | 0.852 | 0.03068 | 3.60 | 0.100 | Pass |

15

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0.391 | 1.653 | 1.791 | 1.684 | 0.10744 | 6.38 | 0.179 | Pass |
| 0.781 | 3.302 | 3.454 | 3.340 | 0.11412 | 3.42 | 0.200 | Pass |
| 1.563 | 6.607 | 6.758 | 6.660 | 0.09798 | 1.47 | 0.203 | Pass |
| 3.125 | 13.211 | 13.531 | 13.293 | 0.23821 | 1.79 | 0.406 | Pass |
| 6.25 | 26.422 | 27.189 | 26.562 | 0.62741 | 2.36 | 0.816 | Pass |
| 12.5 | 52.843 | 53.308 | 53.100 | 0.20814 | 0.39 | 1.599 | Pass |
| 25 | 105.686 | 105.651 | 106.177 | -0.52538 | -0.49 | 5.283 | Pass |
| 50 | 211.372 | 212.634 | 212.330 | 0.30456 | 0.14 | 10.632 | Pass |
| 100 | 422.744* | 422.744 | 424.636 | -1.89156 | -0.45 | 21.137 | Pass |

Deviation from Linearity for WBC 10^3/μL on Instrument BC03130

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0.012 | 0.049 | 0.071 | 0.083 | -0.01241 | -14.94 | 0.100 | Pass |
| 0.024 | 0.098 | 0.129 | 0.132 | -0.00306 | -2.32 | 0.100 | Pass |
| 0.049 | 0.200 | 0.233 | 0.233 | -0.00007 | -0.03 | 0.100 | Pass |
| 0.098 | 0.401 | 0.465 | 0.432 | 0.03330 | 7.71 | 0.100 | Pass |
| 0.195 | 0.797 | 0.885 | 0.825 | 0.05974 | 7.24 | 0.100 | Pass |
| 0.391 | 1.598 | 1.731 | 1.619 | 0.11153 | 6.89 | 0.173 | Pass |
| 0.781 | 3.192 | 3.383 | 3.200 | 0.18221 | 5.69 | 0.200 | Pass |
| 1.563 | 6.388 | 6.487 | 6.371 | 0.11612 | 1.82 | 0.200 | Pass |
| 3.125 | 12.772 | 13.010 | 12.703 | 0.30707 | 2.42 | 0.390 | Pass |
| 6.25 | 25.544 | 25.705 | 25.371 | 0.33456 | 1.32 | 0.771 | Pass |
| 12.5 | 51.088 | 50.632 | 50.707 | -0.07478 | -0.15 | 1.519 | Pass |
| 25 | 102.176 | 101.071 | 101.380 | -0.30880 | -0.30 | 5.054 | Pass |
| 50 | 204.351 | 198.604 | 202.725 | -4.12083 | -2.03 | 9.930 | Pass |
| 100 | 408.702 | 408.702 | 405.416 | 3.28643 | 0.81 | 20.435 | Pass |

Deviation from Linearity for RBC 10^6/µL on Instrument BC03127

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0 | 0.000 | 0.013 | 0.013 | 0.00000 | 0.00 | 0.050 | Pass |
| 10 | 0.858 | 0.856 | 0.867 | -0.01116 | -1.29 | 0.050 | Pass |
| 20 | 1.716 | 1.742 | 1.721 | 0.02100 | 1.22 | 0.050 | Pass |
| 30 | 2.574 | 2.567 | 2.574 | -0.00716 | -0.28 | 0.051 | Pass |
| 40 | 3.432 | 3.433 | 3.428 | 0.00434 | 0.13 | 0.069 | Pass |
| રે0 | 4.290 | 4.344 | 4.282 | 0.06217 | 1.45 | 0.087 | Pass |
| 60 | 5.148 | 5.198 | 5.136 | 0.06234 | 1.21 | 0.104 | Pass |
| 70 | 6.006 | 5.918 | 5.990 | -0.07216 | -1.20 | 0.118 | Pass |
| 80 | 6.865 | 6.872 | 6.844 | 0.02801 | 0.41 | 0.137 | Pass |
| 90 | 7.723 | 7.583 | 7.697 | -0.11449 | -1.49 | 0.152 | Pass |
| 100 | 8.581 | 8.581 | 8.551 | 0.02935 | 0.34 | 0.172 | Pass |

16

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0 | 0.000 | 0.001 | 0.001 | -0.00000 | -0.00 | 0.050 | Pass |
| 10 | 0.856 | 0.857 | 0.844 | 0.01336 | 1.58 | 0.050 | Pass |
| 20 | 1.712 | 1.656 | 1.686 | -0.02994 | -1.78 | 0.050 | Pass |
| 30 | 2.568 | 2.519 | 2.529 | -0.00992 | -0.39 | 0.050 | Pass |
| 40 | 3.424 | 3.416 | 3.372 | 0.04445 | 1.32 | 0.068 | Pass |
| 50 | 4.280 | 4.201 | 4.214 | -0.01319 | -0.31 | 0.084 | Pass |
| 60 | 5.136 | 5.062 | 5.057 | 0.00517 | 0.10 | 0.101 | Pass |
| 70 | 5.992 | 5.895 | 5.899 | -0.00480 | -0.08 | 0.118 | Pass |
| 80 | 6.848 | 6.670 | 6.742 | -0.07244 | -1.07 | 0.133 | Pass |
| 90 | 7.704 | 7.504 | 7.585 | -0.08075 | -1.06 | 0.150 | Pass |
| 100 | 8.560 | 8.560 | 8.427 | 0.13295 | 1.58 | 0.171 | Pass |

Deviation from Linearity for RBC 10^6/µL on Instrument BC03129

Deviation from Linearity for RBC 10^6/µL on Instrument BC03130

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0 | 0.000 | 0.001 | 0.001 | -0.00000 | -0.00 | 0.050 | Pass |
| 10 | 0.859 | 0.858 | 0.843 | 0.01505 | 1.78 | 0.050 | Pass |
| 20 | 1.719 | 1.643 | 1.686 | -0.04258 | -2.53 | 0.050 | Pass |
| 30 | 2.578 | 2.510 | 2.528 | -0.01820 | -0.72 | 0.050 | Pass |
| 40 | 3.437 | 3.419 | 3.370 | 0.04852 | 1.44 | 0.068 | Pass |
| 50 | 4.297 | 4.205 | 4.212 | -0.00777 | -0.18 | 0.084 | Pass |
| 60 | 5.156 | 5.070 | 5.055 | 0.01494 | 0.30 | 0.101 | Pass |
| 70 | 6.015 | 5.950 | 5.897 | 0.05299 | 0.90 | 0.119 | Pass |
| 80 | 6.875 | 6.632 | 6.739 | -0.10730 | -1.59 | 0.133 | Pass |
| 90 | 7.734 | 7.503 | 7.582 | -0.07892 | -1.04 | 0.150 | Pass |
| 100 | 8.593 | 8.593 | 8.424 | 0.16946 | 2.01 | 0.172 | Pass |

Deviation from Linearity for HGB g/dL on Instrument BC03127

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0 | 0.000 | 0.120 | 0.285 | -0.16515 | -57.92 | 0.200 | Pass |
| 10 | 2.607 | 2.823 | 2.860 | -0.03661 | -1.28 | 0.200 | Pass |
| 20 | 5.214 | 5.287 | 5.435 | -0.14806 | -2.72 | 0.200 | Pass |
| 30 | 7.821 | 7.913 | 8.010 | -0.09618 | -1.20 | 0.237 | Pass |
| 40 | 10.428 | 10.803 | 10.584 | 0.21903 | 2.07 | 0.324 | Pass |
| 50 | 13.035 | 13.483 | 13.159 | 0.32424 | 2.46 | 0.405 | Pass |
| 60 | 15.642 | 15.980 | 15.734 | 0.24612 | 1.56 | 0.479 | Pass |
| 70 | 18.249 | 18.560 | 18.309 | 0.25133 | 1.37 | 0.557 | Pass |
| 80 | 20.856 | 20.680 | 20.883 | -0.20345 | -0.97 | 0.620 | Pass |
| 90 | 23.463 | 23.030 | 23.458 | -0.42824 | -1.83 | 0.691 | Pass |
| 100 | 26.070 | 26.070 | 26.033 | 0.03697 | 0.14 | 0.782 | Pass |

17

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0 | 0.000 | 0.057 | 0.122 | -0.06576 | -53.71 | 0.200 | Pass |
| 10 | 2.649 | 2.697 | 2.749 | -0.05218 | -1.90 | 0.200 | Pass |
| 20 | 5.299 | 5.360 | 5.375 | -0.01527 | -0.28 | 0.200 | Pass |
| 30 | 7.948 | 8.047 | 8.002 | 0.04497 | 0.56 | 0.241 | Pass |
| 40 | 10.597 | 10.730 | 10.628 | 0.10188 | 0.96 | 0.322 | Pass |
| 50 | 13.247 | 13.377 | 13.255 | 0.12212 | 0.92 | 0.401 | Pass |
| 60 | 15.896 | 15.937 | 15.881 | 0.05570 | 0.35 | 0.478 | Pass |
| 70 | 18.545 | 18.453 | 18.507 | -0.05406 | -0.29 | 0.554 | Pass |
| 80 | 21.195 | 21.030 | 21.134 | -0.10382 | -0.49 | 0.631 | Pass |
| 90 | 23.844 | 23.620 | 23.760 | -0.14024 | -0.59 | 0.709 | Pass |
| 100 | 26.493 | 26.493 | 26.387 | 0.10667 | 0.40 | 0.795 | Pass |

Deviation from Linearity for HGB g/dL on Instrument BC03129

Deviation from Linearity for HGB g/dL on Instrument BC03130

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0 | 0.000 | 0.140 | 0.242 | -0.10242 | -42.25 | 0.200 | Pass |
| 10 | 2.666 | 2.897 | 2.872 | 0.02461 | 0.86 | 0.200 | Pass |
| 20 | 5.331 | 5.407 | 5.502 | -0.09503 | -1.73 | 0.200 | Pass |
| 30 | 7.997 | 8.090 | 8.131 | -0.04133 | -0.51 | 0.243 | Pass |
| 40 | 10.663 | 11.013 | 10.761 | 0.25236 | 2.35 | 0.330 | Pass |
| 50 | 13.328 | 13.437 | 13.391 | 0.04606 | 0.34 | 0.403 | Pass |
| 60 | 15.994 | 16.060 | 16.020 | 0.03976 | 0.25 | 0.482 | Pass |
| 70 | 18.660 | 18.833 | 18.650 | 0.18345 | 0.98 | 0.565 | Pass |
| 80 | 21.325 | 21.103 | 21.280 | -0.17618 | -0.83 | 0.633 | Pass |
| 90 | 23.991 | 23.660 | 23.909 | -0.24915 | -1.04 | 0.710 | Pass |
| 100 | 26.657 | 26.657 | 26.539 | 0.11788 | 0.44 | 0.800 | Pass |

Deviation from Linearity for PLT 10^3/µL on Instrument BC03127

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0.098 | 2.991 | 3.700 | 4.633 | -0.93316 | -20.14 | 5.000 | Pass |
| 0.195 | 5.951 | 6.767 | 7.635 | -0.86840 | -11.37 | 5.000 | Pass |
| 0.391 | 11.933 | 14.100 | 13.701 | 0.39922 | 2.91 | 5.000 | Pass |
| 0.781 | 23.836 | 26.633 | 25.770 | 0.86303 | 3.35 | 5.000 | Pass |
| 1.563 | 47.703 | 52.733 | 49.971 | 2.76209 | 5.53 | 5.000 | Pass |
| 3.125 | 95.375 | 102.533 | 98.311 | 4.22209 | 4.29 | 5.127 | Pass |
| 6.25 | 190.750 | 202.833 | 195.022 | 7.81116 | 4.01 | 10.142 | Pass |
| 12.5 | 381.500 | 402.867 | 388.444 | 14.42262 | 3.71 | 20.143 | Pass |
| 25 | 763.000 | 795.467 | 775.288 | 20.17887 | 2.60 | 39.773 | Pass |
| 50 | 1526.000 | 1559.700 | 1548.975 | 10.72472 | 0.69 | 77.985 | Pass |
| 100 | 3052.000 | 3052.000 | 3096.350 | -44.35026 | -1.43 | 152.600 | Pass |

18

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0.098 | 2.942 | 3.433 | 4.366 | -0.93287 | -21.37 | 5.000 | Pass |
| 0.195 | 5.855 | 6.533 | 7.332 | -0.79861 | -10.89 | 5.000 | Pass |
| 0.391 | 11.739 | 13.167 | 13.325 | -0.15790 | -1.19 | 5.000 | Pass |
| 0.781 | 23.448 | 26.567 | 25.249 | 1.31800 | 5.22 | 5.000 | Pass |
| 1.563 | 46.926 | 52.200 | 49.158 | 3.04198 | 6.19 | 5.000 | Pass |
| 3.125 | 93.823 | 100.433 | 96.916 | 3.51776 | 3.63 | 5.022 | Pass |
| 6.25 | 187.646 | 201.733 | 192.461 | 9.27207 | 4.82 | 10.087 | Pass |
| 12.5 | 375.292 | 403.633 | 383.553 | 20.08069 | 5.24 | 20.182 | Pass |
| 25 | 750.583 | 779.800 | 765.735 | 14.06461 | 1.84 | 38.990 | Pass |
| 50 | 1501.167 | 1555.267 | 1530.101 | 25.16578 | 1.64 | 77.763 | Pass |
| 100 | 3002.333 | 3002.333 | 3058.832 | -56.49855 | -1.85 | 150.117 | Pass |

Deviation from Linearity for PLT 10^3/µL on Instrument BC03129

Deviation from Linearity for PLT 10^3/μL on Instrument BC03130

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|-----------|-------------|-------------------------|------------|
| 0.098 | 3.029 | 3.367 | 4.120 | -0.75307 | -18.28 | 5.000 | Pass |
| 0.195 | 6.026 | 6.800 | 7.145 | -0.34457 | -4.82 | 5.000 | Pass |
| 0.391 | 12.084 | 12.900 | 13.257 | -0.35660 | -2.69 | 5.000 | Pass |
| 0.781 | 24.137 | 26.100 | 25.418 | 0.68170 | 2.68 | 5.000 | Pass |
| 1.563 | 48.304 | 52.367 | 49.804 | 2.56259 | 5.15 | 5.000 | Pass |
| 3.125 | 96.577 | 103.333 | 98.513 | 4.82009 | 4.89 | 5.167 | Pass |
| 6.25 | 193.154 | 202.933 | 195.963 | 6.97056 | 3.56 | 10.147 | Pass |
| 12.5 | 386.308 | 404.667 | 390.862 | 13.80483 | 3.53 | 20.233 | Pass |
| 25 | 772.617 | 784.367 | 780.660 | 3.70671 | 0.47 | 39.218 | Pass |
| 50 | 1545.233 | 1569.033 | 1560.256 | 8.77714 | 0.56 | 78.452 | Pass |
| 100 | 3090.467 | 3090.467 | 3119.449 | -28.98200 | -0.93 | 154.523 | Pass |

Deviation from Linearity for TNC cells/mm^3 on Instrument BC03127

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|------------|-------------|-------------------------|------------|
| 0.02 | 18.551 | 35.000 | 30.871 | 4.12949 | 13.38 | 5.000 | Pass |
| 0.04 | 37.102 | 45.333 | 49.445 | -4.11131 | -8.31 | 5.000 | Pass |
| 0.06 | 55.652 | 63.667 | 68.019 | -4.35212 | -6.40 | 6.367 | Pass |
| 0.08 | 74.203 | 89.667 | 86.593 | 3.07374 | 3.55 | 8.967 | Pass |
| 0.1 | 92.754 | 97.000 | 105.167 | -8.16707 | -7.77 | 9.700 | Pass |
| 10 | 9275.400 | 9295.000 | 9299.367 | -4.36665 | -0.05 | 929.500 | Pass |
| 20 | 18550.800 | 19726.000 | 18586.437 | 1139.56307 | 6.13 | 1972.600 | Pass |
| 30 | 27826.200 | 27860.667 | 27873.507 | -12.84054 | -0.05 | 2786.067 | Pass |
| 40 | 37101.600 | 36818.333 | 37160.577 | -342.24416 | -0.92 | 3681.833 | Pass |
| 50 | 46377.000 | 46537.667 | 46447.648 | 90.01890 | 0.19 | 4653.767 | Pass |
| 60 | 55652.400 | 55888.333 | 55734.718 | 153.61528 | 0.28 | 5588.833 | Pass |
| 70 | 64927.800 | 64934.000 | 65021.788 | -87.78833 | -0.14 | 6493.400 | Pass |
| 80 | 74203.200 | 74464.667 | 74308.859 | 155.80806 | 0.21 | 7446.467 | Pass |
| 90 | 83478.600 | 82905.000 | 83595.929 | -690.92889 | -0.83 | 8290.500 | Pass |
| 100 | 92754.000 | 92754.000 | 92882.999 | -128.99917 | -0.14 | 9275.400 | Pass |

19

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|------------|-------------|-------------------------|------------|
| 0.02 | 18.972 | 27.333 | 29.292 | -1.95844 | -6.69 | 5.000 | Pass |
| 0.04 | 37.944 | 47.667 | 48.503 | -0.83605 | -1.72 | 5.000 | Pass |
| 0.06 | 56.916 | 67.000 | 67.714 | -0.71366 | -1.05 | 6.700 | Pass |
| 0.08 | 75.887 | 90.333 | 86.925 | 3.40873 | 3.92 | 9.033 | Pass |
| 0.1 | 94.859 | 102.000 | 106.136 | -4.13555 | -3.90 | 10.200 | Pass |
| 10 | 9485.933 | 9593.000 | 9615.552 | -22.55231 | -0.23 | 959.300 | Pass |
| 20 | 18971.867 | 20269.333 | 19221.024 | 1048.30955 | 5.45 | 2026.933 | Pass |
| 30 | 28457.800 | 28782.333 | 28826.495 | -44.16193 | -0.15 | 2878.233 | Pass |
| 40 | 37943.733 | 38453.667 | 38431.967 | 21.69993 | 0.06 | 3845.367 | Pass |
| 50 | 47429.667 | 47965.667 | 48037.438 | -71.77155 | -0.15 | 4796.567 | Pass |
| 60 | 56915.600 | 57668.667 | 57642.910 | 25.75698 | 0.04 | 5766.867 | Pass |
| 70 | 66401.533 | 66629.333 | 67248.381 | -619.04783 | -0.92 | 6662.933 | Pass |
| 80 | 75887.467 | 77711.333 | 76853.853 | 857.48069 | 1.12 | 7771.133 | Pass |
| 90 | 85373.400 | 86751.333 | 86459.324 | 292.00921 | 0.34 | 8675.133 | Pass |
| 100 | 94859.333 | 94859.333 | 96064.796 | -1205.4623 | -1.25 | 9485.933 | Pass |

Deviation from Linearity for TNC cells/mm^3 on Instrument BC03129

Deviation from Linearity for TNC cells/mm^3 on Instrument BC03130

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit ($\pm$) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|------------|-------------|-------------------------------|------------|
| 0.02 | 18.885 | 31.333 | 31.494 | -0.16058 | -0.51 | 5.000 | Pass |
| 0.04 | 37.769 | 50.000 | 50.452 | -0.45154 | -0.89 | 5.000 | Pass |
| 0.06 | 56.654 | 68.000 | 69.409 | -1.40917 | -2.03 | 6.800 | Pass |
| 0.08 | 75.539 | 90.667 | 88.367 | 2.29988 | 2.60 | 9.067 | Pass |
| 0.1 | 94.424 | 98.667 | 107.324 | -8.65775 | -8.07 | 9.867 | Pass |
| 10 | 9442.367 | 9505.667 | 9491.349 | 14.31801 | 0.15 | 950.567 | Pass |
| 20 | 18884.733 | 20211.000 | 18970.161 | 1240.83898 | 6.54 | 2021.100 | Pass |
| 30 | 28327.100 | 28414.667 | 28448.973 | -34.30672 | -0.12 | 2841.467 | Pass |
| 40 | 37769.467 | 37804.667 | 37927.786 | -123.11908 | -0.32 | 3780.467 | Pass |
| 50 | 47211.833 | 46924.000 | 47406.598 | -482.59811 | -1.02 | 4692.400 | Pass |
| 60 | 56654.200 | 57072.333 | 56885.410 | 186.92286 | 0.33 | 5707.233 | Pass |
| 70 | 66096.567 | 65844.667 | 66364.223 | -519.55617 | -0.78 | 6584.467 | Pass |
| 80 | 75538.933 | 75947.333 | 75843.035 | 104.29813 | 0.14 | 7594.733 | Pass |
| 90 | 84981.300 | 85579.333 | 85321.848 | 257.48577 | 0.30 | 8557.933 | Pass |
| 100 | 94423.667 | 94423.667 | 94800.660 | -376.99326 | -0.40 | 9442.367 | Pass |

Deviation from Linearity for BF RBC on Instrument BC03127

| Dilution | Expected
Value | Mean of
Measured Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|---------------------------|-----------------------------------|------------|-------------|-------------------------|------------|
| 0.015 | 954.328 | 1205.333 | 1144.669 | 60.66387 | 5.30 | 500.000 | Pass |
| 0.02 | 1272.438 | 1705.333 | 1463.115 | 242.21809 | 16.55 | 500.000 | Pass |
| 0.04 | 2544.875 | 2654.333 | 2736.898 | -82.56504 | -3.02 | 500.000 | Pass |
| 0.06 | 3817.313 | 4231.333 | 4010.682 | 220.65183 | 5.50 | 500.000 | Pass |
| 0.08 | 5089.751 | 5632.667 | 5284.465 | 348.20204 | 6.59 | 500.000 | Pass |
| 0.1 | 6362.188 | 6485.333 | 6558.248 | -72.91442 | -1.11 | 500.000 | Pass |
| 20 | 1272437.67 | 1277341.33 | 1273972.46 | 3368.87281 | 0.26 | 63867.067 | Pass |

20

| Dilution | Expected
Value | Mean of
Measured Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|---------------------------|-----------------------------------|------------|-------------|-------------------------|------------|
| 30 | 1908656.50 | 1891584.67 | 1910864.02 | -19279.358 | -1.01 | 94579.233 | Pass |
| 40 | 2544875.33 | 2490719.33 | 2547755.59 | -57036.256 | -2.24 | 124535.967 | Pass |
| 50 | 3181094.17 | 3199415.67 | 3184647.15 | 14768.5135 | 0.46 | 159970.783 | Pass |
| 60 | 3817313.00 | 3813229.67 | 3821538.72 | -8309.0507 | -0.22 | 190661.483 | Pass |
| 70 | 4453531.83 | 4495862.00 | 4458430.28 | 37431.7184 | 0.84 | 224793.100 | Pass |
| 80 | 5089750.67 | 5112301.67 | 5095321.85 | 16979.8209 | 0.33 | 255615.083 | Pass |
| 90 | 5725969.50 | 5736287.67 | 5732213.41 | 4074.25670 | 0.07 | 286814.383 | Pass |
| 100 | 6362188.33 | 6362188.33 | 6369104.97 | -6916.6408 | -0.11 | 318109.417 | Pass |

Deviation from Linearity for BF RBC on Instrument BC03129

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|------------|-------------|-------------------------|------------|
| 0.015 | 957.169 | 1145.000 | 1122.947 | 22.05325 | 1.96 | 500.000 | Pass |
| 0.02 | 1276.225 | 1530.333 | 1442.930 | 87.40381 | 6.06 | 500.000 | Pass |
| 0.04 | 2552.450 | 2803.333 | 2722.861 | 80.47273 | 2.96 | 500.000 | Pass |
| 0.06 | 3828.675 | 3959.667 | 4002.792 | -43.12502 | -1.08 | 500.000 | Pass |
| 0.08 | 5104.900 | 5676.667 | 5282.723 | 393.94390 | 7.46 | 500.000 | Pass |
| 0.1 | 6381.125 | 6627.000 | 6562.654 | 64.34616 | 0.98 | 500.000 | Pass |
| 20 | 1276225.00 | 1274035.67 | 1280094.08 | -6058.4121 | -0.47 | 63701.783 | Pass |
| 30 | 1914337.50 | 1892034.00 | 1920059.62 | -28025.619 | -1.46 | 94601.700 | Pass |
| 40 | 2552450.00 | 2528795.33 | 2560025.16 | -31229.826 | -1.22 | 126439.767 | Pass |
| ર૦ | 3190562.50 | 3237730.67 | 3199990.70 | 37739.9675 | 1.18 | 161886.533 | Pass |
| 60 | 3828675.00 | 3843700.67 | 3839956.24 | 3744.42739 | 0.10 | 192185.033 | Pass |
| 70 | 4466787.50 | 4521090.67 | 4479921.78 | 41168.8873 | 0.92 | 226054.533 | Pass |
| 80 | 5104900.00 | 5113788.00 | 5119887.32 | -6099.3196 | -0.12 | 255689.400 | Pass |
| 90 | 5743012.50 | 5759083.67 | 5759852.86 | -769.19302 | -0.01 | 287954.183 | Pass |
| 100 | 6381125.00 | 6381125.00 | 6399818.40 | -18693.400 | -0.29 | 319056.250 | Pass |

Deviation from Linearity for BF RBC on Instrument BC03130

| Dilution | Expected
Value | Mean of
Measured
Value | Predicted
Value from
linear | Deviation | % Deviation | Acceptance
Limit (±) | Conclusion |
|----------|-------------------|------------------------------|-----------------------------------|------------|-------------|-------------------------|------------|
| 0.015 | 953.086 | 1047.000 | 1113.100 | -66.09964 | -5.94 | 500.000 | Pass |
| 0.02 | 1270.781 | 1712.667 | 1433.869 | 278.79789 | 19.44 | 500.000 | Pass |
| 0.04 | 2541.563 | 2663.333 | 2716.945 | -53.61197 | -1.97 | 500.000 | Pass |
| 0.06 | 3812.344 | 4286.333 | 4000.022 | 286.31151 | 7.16 | 500.000 | Pass |
| 0.08 | 5083.125 | 5300.000 | 5283.098 | 16.90165 | 0.32 | 500.000 | Pass |
| 0.1 | 6353.906 | 6897.667 | 6566.175 | 331.49179 | 5.05 | 500.000 | Pass |
| 20 | 1270781.27 | 1266443.67 | 1283227.32 | -16783.653 | -1.31 | 63322.183 | Pass |
| 30 | 1906171.90 | 1899907.67 | 1924765.58 | -24857.916 | -1.29 | 94995.383 | Pass |
| 40 | 2541562.53 | 2527694.00 | 2566303.85 | -38609.847 | -1.50 | 126384.700 | Pass |
| 50 | 3176953.17 | 3219698.67 | 3207842.11 | 11856.5565 | 0.37 | 160984.933 | Pass |
| 60 | 3812343.80 | 3871521.00 | 3849380.37 | 22140.6263 | 0.58 | 193576.050 | Pass |
| 70 | 4447734.43 | 4590433.00 | 4490918.64 | 99514.3627 | 2.22 | 229521.650 | Pass |
| 80 | 5083125.07 | 5142751.33 | 5132456.90 | 10294.4324 | 0.20 | 257137.567 | Pass |
| 90 | 5718515.70 | 5764944.33 | 5773995.16 | -9050.8312 | -0.16 | 288247.217 | Pass |
| 100 | 6353906.33 | 6353906.33 | 6415533.43 | -61627.095 | -0.96 | 317695.317 | Pass |

21

The data presented in this submission supports the linear range for whole blood and body fluids as described in the Instructions for Use. The data supports that connection of instruments into a workcell configuration does not significantly impact the linearity.

Parameter	Units	Linearity Range Results
WBC	103 cells/µL	0.064 - 408.5
RBC	106 cells/µL	0.001 - 8.560
PLT	103 cells/µL	3.2 - 3002
HGB	g/dL	0.04 - 26.070
BF-RBC	cells/mm3	1113.10 - 6,353,906
BF-TNC	cells/mm3	31.50 - 92,745

e) Carryover: Whole Blood and Body Fluid High to Low Carryover was conducted on the DxH 900-3S workcell per CLSI H26-A2. Three (3) test instruments were used for each of the WBC, RBC, Hgb, and PLT parameters. One (1) replicate from each of the three (3) High Target Value tubes followed by one (1) replicate from each of the three (3) Low Target Value tubes were analyzed. Each of the Low Target Value tubes was only aspirated once. This step was repeated three (3) times for each parameter. The WBC, RBC, Hgb, and PLT parameters for Carryover were calculated using the formula % carryover = [(LTV 1-LTV 3)(HTV 3-LTV 3)] X100, where HTV=high target value, LTV=low target value. The data presented in the submission supports there is no detectable carryover for whole blood or body fluids as described in the Instructions for Use. The data supports that connection of instruments into a workcell configuration does not impact carryover.
f) Performance Detection Capability Limits: Limit of Blank (LoB), Lower Limit of Detection (LLoD) and Lower Limit of Quantitation (LLoQ) was conducted on the DxH 900-3S workcell per CLSI EP17-A2 to evaluate the LoB, LLoQ for WBC, PLT, BF-RBC, and BF-TNC.

LoB was performed using DxH diluent as blank in the CBC, CDR, CD and CR test panel in cassette presentation, five (5) replicates of each panel were analyzed for a total of twenty (20) replicates in the AM and PM for three (3) days for a total of 120 whole blood cassette presentation cycles. Twenty (20) replicates of DxH diluent (blank) were analyzed in the single tube presentation as BF cycle in the AM and PM for three (3) days for a total of 120 single tube BF cycles. In both scenarios, two (2) lots of DxH diluent and DxH Cell Lyse reagents were used.

To test for LLoD and LLoQ, a dilution of a fresh whole blood sample was prepared to obtain a stock solution with a value in one of the following target ranges (WBC 60-70 x 103/μL, PLT 7-9 x 103/μL, TNC 45-50 cells/mm3, and BF-RBC 2450- 2470 cells/mm3). Four (4) samples per parameter were obtained for a total of sixteen (16) samples per instrument. Three (3) sets of eleven (11) dilutions of the stock solution were prepared in 10% increments from 0% to 100%. One (1) set of dilutions was analyzed on each of the test instruments. Five (5) replicates of each dilution level were analyzed on each test instrument in the CBC test panel for WBC and PLT and five (5) replicates of each were analyzed on each instrument in the BFC test panel for TNC and BF-RBC.

Bias was established by analyzing five (5) normal whole blood samples each day in duplicate on the test instruments and DxH 800 comparator using the CBC test panel.

22

The limit of quantitation data provided supports the intended use of the device and the lower limit of the analytical measuring interval per the instructions for use. The data supports that connection of instruments into a workcell configuration does not significantly impact the analytical measuring range. For WBC, PLT, BF-TNC, and BF-RBC, LLoQ are aligned with the background limit and the lower limit of the measuring range. These are parameters where there is a clinical interest (medical decision level) on very low or near zero values.

LLoQ Results

| Parameter | Units | Acceptance limit
(LoQ) | LoQ result |
|-----------|---------------|---------------------------|------------|
| WBC | x103 cells/μL | ≤0.050 | 0.019 |
| PLT | x103 cells/μL | ≤3.000 | 0.757 |
| BF TNC | cells/mm3 | ≤20.000 | 14.004 |
| BF RBC | cells/mm3 | ≤1000.000 | 979.869 |

g) Reference Ranges: Studies to assess the Adult Reference Interval (Whole Blood) were conducted on the DxH 900 per CLSI EP28-A3c to verify the reference intervals for male and female adults on the DxH 900/DxH 690T Analyzer are the same as the DxH 800 Analyzer (predicate). The data verifies the DxH 800 references ranges presented in the IFU are transferable to the DxH 900/DxH 690T. The data supports that connected workcells have the same reference ranges as a stand-alone instrument.

Reference Ranges for Adults Combined Male and Female

Parameter	Unit	Mean	95% Confidence Lower Limit	95% Confidence Upper Limit
WBC	x 103 cells/µL	6.3	3.6	11.2
RBC	x 106 cells/µL	4.52	3.73	5.50
Hemoglobin	g/dL	13.4	11.4	15.9
HCT	%	39.0	33.3	45.7
MCV	fL	86.4	73.7	95.5
MCH	pg	29.6	24.3	33.2
MCHC	g/dL	34.2	32.5	35.8
RDW	%	13.8	12.3	17.0
RDW-SD	fL	41.4	37.1	47.8
Platelet	x 103 cells/µL	257	159	386
MPV	fL	9.2	7.5	11.2
Neutrophil	%	58.5	43.3	76.6
Lymphocyte	%	29.6	16.0	43.5
Monocyte	%	8.3	4.5	12.5
Eosinophil	%	2.8	0.6	7.9
Basophil	%	0.7	0.2	1.4
Neutrophil	x 103 cells/µL	3.7	1.8	7.8
Lymphocyte	x 103 cells/µL	1.8	1.0	3.0
Monocyte	x 103 cells/µL	0.5	0.3	1.0
Eosinophil	x 103 cells/µL	0.2	0.0	0.5
Basophil	x 103 cells/µL	0.0	0.0	0.1
Reticulocyte	%	1.10	0.50	2.17
Reticulocyte	x 106 cells/µL	0.0498	0.0221	0.0963
MRV	fL	108.8	97.4	120.2
IRF	NA	0.40	0.29	0.53
NRBC	%	0.1	0.0	0.4
NRBC	x 103 cells/µL	0.01	0.00	0.02

23

Reference Ranges for Adult Females

Parameter	Unit	Mean	95% Confidence Lower	95% Confidence Upper
WBC	x 103 cells/uL	6.7	3.8	11.8
RBC	x 106 cells/uL	4.26	3.63	4.92
Hemoglobin	g/dL	12.6	10.9	14.3
HCT	%	36.9	31.2	41.9
MCV	fL	86.8	75.5	95.3
MCH	pg	29.6	24.7	32.8
MCHC	g/dL	34.1	32.3	35.6
RDW	%	14.0	12.3	17.7
RDW-SD	fL	42.0	37.6	50.3
Platelet	x 103 cells/uL	278	179	408
MPV	fL	9.2	7.9	10.8
Neutrophil	%	59.7	42.7	76.8
Lymphocyte	%	29.4	16.0	45.9
Monocyte	%	7.6	4.3	10.9
Eosinophil	%	2.4	0.5	7.0
Basophil	%	0.7	0.2	1.3
Neutrophil	x 103 cells/uL	4.1	1.9	8.2
Lymphocyte	x 103 cells/uL	1.9	1.1	3.1
Monocyte	x 103 cells/uL	0.5	0.2	0.9
Eosinophil	x 103 cells/uL	0.2	0.0	0.5
Basophil	x 103 cells/uL	0.0	0.0	0.1
Reticulocyte	%	1.11	0.51	2.17
Reticulocyte	x 106 cells/uL	0.04	0.0230	0.0935
MRV	fL	108.	96.4	118.0
IRF	NA	0.40	0.26	0.52
NRBC	%	0.1	0.0	0.3
NRBC	x 103 cells/uL	0.01	0.00	0.02

Reference Ranges for Adult Males

| Parameter | Unit | Mean | 95%
Confidence Lower | 95%
Confidence Upper |
|--------------|----------------|--------|-------------------------|-------------------------|
| WBC | x 103 cells/µL | 5.9 | 3.6 | 10.2 |
| RBC | x 106 cells/µL | 4.81 | 4.06 | 5.63 |
| Hemoglobin | g/dL | 14.2 | 12.5 | 16.3 |
| HCT | % | 41.3 | 36.7 | 47.1 |
| MCV | fL | 86.1 | 73.0 | 96.2 |
| MCH | pg | 29.6 | 23.8 | 33.4 |
| MCHC | g/dL | 34.4 | 32.5 | 36.3 |
| RDW | % | 13.6 | 12.1 | 16.2 |
| RDW-SD | fL | 40.8 | 36.5 | 45.9 |
| Platelet | x 103 cells/µL | 234 | 152 | 348 |
| MPV | fL | 9.2 | 7.4 | 11.4 |
| Neutrophil | % | 57.3 | 43.5 | 73.5 |
| Lymphocyte | % | 29.8 | 15.2 | 43.3 |
| Monocyte | % | 9.0 | 5.5 | 13.7 |
| Eosinophil | % | 3.2 | 0.8 | 8.1 |
| Basophil | % | 0.7 | 0.2 | 1.5 |
| Neutrophil | x 103 cells/µL | 3.4 | 1.7 | 7.6 |
| Lymphocyte | x 103 cells/µL | 1.7 | 1.0 | 3.2 |
| Monocyte | x 103 cells/µL | 0.5 | 0.3 | 1.1 |
| Eosinophil | x 103 cells/µL | 0.2 | 0.0 | 0.5 |
| Basophil | x 103 cells/µL | 0.0 | 0.0 | 0.1 |
| Reticulocyte | % | 1.09 | 0.42 | 2.23 |
| Reticulocyte | x 106 cells/µL | 0.0523 | 0.0188 | 0.1086 |
| MRV | fL | 109.5 | 97.5 | 122.7 |

24

IRF	NA	0.41	0.30	0.54
NRBC	%	0.2	0.0	0.6
NRBC	x 103 cells/µL	0.01	0.00	0.02

h) Whole Blood Method Comparison was tested according to EP09c & CLSI H26-A2 to support substantial equivalency by comparison of the CBC, NRBC, DIFF and RETIC values obtained on the DxH 800 Analyzer (predicate) to the values obtained on the DxH 900 Analyzer . This included adult and pediatric samples. The data provided for whole blood method comparison is comprehensive, covering the analytical measurement interval (AMI). Data was collected from multiple sites on both stand-alone and connected workcell instrument configurations using both legacy and ECO reagents. Data were analyzed pooled and by site to support the substantial equivalence of the DxH 900 to the DxH 800 for CBC, NRBC, DIFF and RETIC parameters. This data supports the intended use of the DxH 900 in stand-alone and connected workcell configurations and supports the use of ECO reagents.

Parameter	Unit	N	Reference			Test			Difference	95% Confidence Limits
			Mean	Min	Max	Mean	Min	Max		Lower	Upper
HCT	%	734	32.65	8.46	61.94	32.35	8.40	60.67	-0.297	-0.333	-0.260
MCH	pg	733	29.62	13.72	73.63	29.72	14.14	73.76	0.099	0.067	0.131
MCHC	g/dL	733	33.23	25.31	57.50	33.47	26.09	57.50	0.236	0.199	0.273
NE	10^3 cells/µL	673	6.69	0.01	92.84	6.77	0.01	94.69	0.082	0.030	0.134
LY	10^3 cells/µL	673	4.33	0.04	257.99	4.32	0.05	257.91	-0.020	-0.049	0.010
MO	10^3 cells/µL	670	0.98	0.00	56.47	0.99	0.00	58.59	0.004	-0.010	0.017
EO	10^3 cells/µL	647	0.19	0.00	4.71	0.18	0.00	1.92	-0.005	-0.017	0.006
BA	10^3 cells/µL	666	0.06	0.00	0.85	0.06	0.00	1.21	0.003	-0.001	0.007
RETc	10^6 cells/µL	726	0.07	0.00	0.82	0.08	0.00	0.89	0.003	0.002	0.003
NRBCc	10^3 cells/µL	616	0.11	0.00	30.23	0.11	0.00	34.92	0.008	-0.008	0.023
RBC	10^6 cells/µL	734	3.73	0.94	8.20	3.71	0.93	8.06	-0.020	-0.023	-0.016
HGB	g/dL	734	10.83	2.96	19.76	10.81	2.97	19.64	-0.022	-0.029	-0.016
MCV	fL	734	88.97	54.20	128.05	88.63	54.19	128.29	-0.342	-0.386	-0.297
RDW	%	733	16.50	11.97	39.78	16.49	12.08	39.15	-0.004	-0.035	0.027
RDWSD	fL	733	51.30	34.13	99.75	51.01	33.69	98.44	-0.288	-0.377	-0.199
PLT	10^3 cells/µL	687	263.10	3.57	1477.44	263.03	3.86	1449.60	-0.075	-0.743	0.592
MPV	fL	687	8.68	6.14	12.83	8.75	6.22	13.30	0.076	0.058	0.094
NE	%	681	63.59	0.31	97.65	63.61	1.02	97.62	0.014	-0.068	0.096
LY	%	681	24.06	0.97	98.44	24.08	0.62	98.09	0.014	-0.067	0.095
MO	%	678	9.66	0.34	97.44	9.65	0.32	97.62	-0.014	-0.075	0.048
EO	%	655	2.18	0.01	18.63	2.16	0.01	18.26	-0.017	-0.038	0.004
BA	%	674	0.63	0.01	5.58	0.64	0.03	6.34	0.007	-0.017	0.031
RETp	%	727	2.18	0.02	22.15	2.26	0.04	23.79	0.075	0.053	0.096
IRF	N/A	723	0.44	0.02	0.86	0.45	0.03	0.83	0.002	-0.002	0.005
MRV	fL	727	116.60	75.50	168.01	115.49	83.20	169.45	-1.115	-1.373	-0.858
WBC	10^3 cells/µL	723	11.84	0.08	273.54	11.90	0.08	282.90	0.055	0.011	0.098
NRBC	%	619	0.62	0.01	115.54	0.61	0.01	130.63	-0.005	-0.056	0.047

General Statistics for All Sites Combined

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			95% Confidence Limits			95% Confidence Limits			95% Confidence Limits
Parameter	Unit	Slope	Lower	Upper	Intercept	Lower	Upper	Correlation	Lower	Upper
HCT	%	0.987	0.983	0.992	0.117	-0.010	0.243	0.99860	0.99838	0.99879
MCH	pg	1.019	0.999	1.039	-0.464	-1.051	0.124	0.99420	0.99330	0.99498
MCHC	g/dL	1.024	0.982	1.066	-0.571	-1.970	0.828	0.95210	0.94483	0.95843
NE	10^3 cells/µL	1.010	1.004	1.017	0.000	-0.000	0.000	0.99490	0.99407	0.99562
LY	10^3 cells/µL	1.003	0.995	1.011	-0.003	-0.009	0.003	0.99980	0.99977	0.99983
MO	10^3 cells/µL	0.994	0.985	1.003	0.003	0.001	0.004	0.99850	0.99825	0.99871
EO	10^3 cells/µL	1.008	0.986	1.029	0.00002	-0.00033	0.00038	0.84660	0.82324	0.86710
BA	10^3 cells/µL	1.010	0.940	1.080	0.0002	-0.0014	0.0019	0.68370	0.64102	0.72216
RETc	10^6 cells/µL	1.028	1.016	1.040	0.0004	0.0002	0.0006	0.98720	0.98521	0.98893
NRBCc	10^3 cells/µL	0.834	0.746	0.922	0.00002	-0.00040	0.00044	0.99930	0.99918	0.99940
RBC	10^6 cells/µL	0.994	0.990	0.997	0.005	-0.006	0.016	0.99920	0.99908	0.99931
HGB	g/dL	0.995	0.992	0.997	0.035	0.009	0.060	0.99950	0.99942	0.99957
MCV	fL	0.998	0.990	1.006	-0.163	-0.872	0.546	0.99780	0.99746	0.99810
RDW	%	0.999	0.967	1.032	0.004	-0.501	0.510	0.99260	0.99145	0.99360
RDWSD	fL	0.980	0.966	0.993	0.761	0.127	1.394	0.99400	0.99307	0.99481
PLT	10^3 cells/µL	1.000	0.996	1.004	0.025	-0.457	0.507	0.99890	0.99872	0.99905
MPV	fL	1.012	0.991	1.033	-0.025	-0.200	0.151	0.97770	0.97414	0.98077
NE	%	1.001	0.997	1.005	-0.050	-0.321	0.221	0.99860	0.99837	0.99880
LY	%	1.001	0.996	1.005	-0.002	-0.117	0.112	0.99840	0.99814	0.99862
MO	%	1.005	0.992	1.018	-0.058	-0.174	0.057	0.99580	0.99512	0.99639
EO	%	0.985	0.969	1.000	0.016	-0.013	0.046	0.99310	0.99196	0.99408
BA	%	0.888	0.709	1.066	0.078	-0.022	0.177	0.81790	0.79125	0.84145
RETp	%	1.014	0.984	1.045	0.044	-0.011	0.098	0.99210	0.99087	0.99317
IRF	N/A	0.985	0.955	1.015	0.008	-0.006	0.023	0.93350	0.92344	0.94228
MRV	fL	1.001	0.980	1.021	-1.205	-3.571	1.161	0.97160	0.96722	0.97540
WBC	10^3 cells/µL	1.006	1.003	1.009	0.003	-0.009	0.015	0.99960	0.99954	0.99965
NRBC	%	1.115	0.876	1.354	-0.075	-0.174	0.023	0.99830	0.99801	0.99855

Regression Statistics and Correlation for All Sites Combined

i) Body Fluid Method Comparison was tested according to EP09c, CLSI H26-A2 and CLSI H56 to establish equivalency of the Body Fluid obtained on the DxH 800 Analyzer (Predicate) to the values obtained on the DxH 900 Analyzer (subject). The data for body fluid method comparison is comprehensive data covering the AMI, from multiple sites including stand-alone and connected workcell instrument configurations using both legacy and ECO reagents. Data were analyzed pooled and by site to support the substantial equivalence of the DxH 900 to the DxH 800 for BF-TNC and BF-RBC parameters. This data supports the intended use of the DxH 900 in stand-alone and connected workcell configuration and supports the use of ECO reagents.

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General Statistics of BF for All Sites Combined

Parameter	Unit	N	Reference			Test			Difference	95% Confidence Limit
			Mean	Min	Max	Mean	Min	Max		Lower	Upper
BF RBC	cells/mm^3	130	1155683.06	1017.44	6001500.00	1158284.86	1085.99	6034566.00	2601.802	-1857.223	7060.827
BF TNC	cells/mm^3	195	2837.31	20.69	56226.96	2888.18	25.01	56066.86	50.878	29.921	71.834

Regression Statistics and Correlation of BF for All Sites Combined

Parameter	Unit	Slope	95% Confidence Limits		Intercept	95% Confidence Limits		Correlation	95% Confidence Limits
			Lower	Upper		Lower	Upper		Lower	Upper
BF RBC	cells/mm^3	0.998	0.991	1.005	-18.721	-95.808	58.367	0.99991	0.99988	0.99994
BF TNC	cells/mm^3	1.014	1.000	1.027	1.101	-1.626	3.827	0.99989	0.99985	0.99992

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Flagging analysis was conducted to evaluate the flagging capabilities of the DxH 900 using i) the flagging results obtained from the samples used in the method comparison study, from three (3) clinical sites, based on CLSI H20-A2 guidelines. A total of 735 residual normal (no flags, marked as negative) and abnormal (contained flags, marked as positive) whole blood samples were tested and compared to the predicate.
The results were classified according to the following categories:
TN (True negative): DxH 900 result and predicate result are both negative (normal sample).
TP (True positive): DxH 900 result and predicate result are both positive (abnormal ● sample).
. FN (False Negative): DxH 900 gives a negative result (normal sample) whereas predicate gives a positive result (abnormal sample).
FP (False Positive): DxH 900 gives a positive result (abnormal sample) whereas predicate . gives a negative result (normal sample).

The NPA, PPA and OPA were calculated for each pathology and abnormality, using the following calculations:

Negative Percent Agreement (NPA): TN / (TN+FP) Positive Percent Agreement (PPA): TP / (TP+FN) Overall Percent Agreement (OPA): (TP+TN) / (TP+FN+FP+TN)

A summary of the results is presented in the table below. All of the distributional cases described in CLSI H20 are important medical decision levels and showed good clinical negative and positive percent agreement between the DxH 900 and DxH 800. The morphological agreement was based on DxH 800 (predicate) flagging for immature granulocytes, variant lymphocytes and left shift. Morphological results showed good clinical negative and positive percent agreement between the DxH 900 and DxH 800.

| Category of
Abnormalities | N | TP | FP | FN | TN | NPA
(95% Confidence
Limits) | PPA
(95% Confidence
Limits) | OPA
(95% Confidence
Limits) |
|------------------------------------------|-----|-----|----|----|-----|-----------------------------------|-----------------------------------|-----------------------------------|
| Morphological
Abnormalities
for WB | 735 | 193 | 23 | 25 | 494 | .9555
(0.9341 to 0.9702) | 0.8853
(0.8362 to 0.9211) | 0.9347
(0.9145 to 0.9504) |
| Distributional
Study of WB | 735 | 419 | 35 | 22 | 259 | .8810
(0.8389 to 0.9131) | 0.9501
(0.9256 to 0.9668) | 0.9224
(0.9008 to 0.9397) |

Flagging Study NPA, PPA, OPA

k) DxH 690T The only differences between the UniCel DxH 900 Coulter Cellular Analysis System and UniCel DxH 690T Coulter Cellular Analysis System are the designed inability to connect as part of a workcell and the lack of the base cabinet with the quad diluent feature (ability to load 4 diluent boxes). All other hardware and software are identical on the DxH 900 and DxH 690T instruments. In order to show that analytical and clinical study data collected on a DxH 900 would also be representative of the DxH 690T, performance verification testing was completed. Testing was performed on one (1) DxH 690T along with one (1) DxH 900 and for accuracy, one (1) DxH 800. Test cases included Daily Checks, Daily Shutdown, Calibration and Initial Control Recover, Daily Control Recovery, Repeatability, Linearity using LIN-X Linearity Control, Comparability- whole blood

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accuracy, and Carryover. All test cases met the predetermined acceptance criteria. Results of each test case are summarized here:

Daily Checks The Daily Checks cvcle was performed on days when testing was O performed before analysis of control material or blood specimens. Daily Checks results were within the instrument limits and background limits shown each day before the analysis of control material or blood specimens.

Parameter	Limit
WBC	$\leq$ 0.05 x $10^3$ /uL
RBC	$\leq$ 0.005 x $10^6$ /uL
HGB	$\leq$ 0.1 g/dL
PLT	$\leq$ 3 x $10^3$ /uL
NRBC Region	$\leq$ 10 Events
NRBC Total	$\leq$ 60 Events
DIFF	$\leq$ 100 Events
RET	$\leq$ 600 Events

Background Limits

Daily Shutdown A shutdown cycle was performed each day prior to Daily O Checks according to the IFU. The shutdown cvcle was performed successfully each day following completion of the testing or in the morning prior to the Daily Checks cycle. The Shutdown cycle put cleaner into the system and removed cleaner and left the instrument ready for the Daily Checks cycle.
Calibration and Initial Control Recovery Initial calibration was performed on the o test instruments using the COULTER S-Cal Calibrator. Calibration was verified by analyzing each level of COULTER 6C Plus Cell Control. Calibration was initially performed using S-Cal lot 113161240, expiration 5/4/19. The HGB and MCV were adjusted on Instrument SN BC09305, and the RBC parameter was adjusted on Instrument SN BA51011. For verification, all three levels of 6C Plus Cell Control recovered within the expected ranges set for each level on all test instruments.
Daily Control Recovery A minimum of one replicate of COULTER Latron CPo X was analyzed each day after the Daily Checks cycle. A minimum of one replicate of each level of COULTER 6C Plus Cell Control, and COULTER Retic-X Cell Control was analyzed each day during the evaluation period. The controls were analyzed each day that testing was performed on an instrument. In the event of a flag, partial aspiration or non-numeric result on a control run, the control was repeated. In each case, a control result was recovered within the assigned ranges and without flags. For all test instruments, results for all controls were within the expected assay ranges prior to data collection each day data collection was performed.
Repeatability Within Run Repeatability for the CBC, Differential, NRBC and O Reticulocyte parameters was performed using ten aspirations (n=10) in the automatic CDR test panel. The customer "Repeatability" application in the software was used to capture the results. Repeatability testing was performed using a combination of normal whole blood samples, abnormal samples, manipulated samples, and COULTER 6C Plus Cell Control Level 2 and Level 3

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to obtain the ranges for each parameter required. Testing was performed across three (3) days. The test instruments met the repeatability specifications for all parameters. The COULTER 6C Plus Cell Control Level 2 was used to obtain NRBC >2-5 and COULTER 6C Plus Cell Control Level 3 was used to obtain NRBC >15. Results are listed in the tables below.

| Parameter | Level | Specification | N | Test Result
Mean | Test Result
%CV or
SD | Acceptance |
|-----------|-----------------|---------------------------|----|---------------------|-----------------------------|------------|
| WBC | 5.00 - 10.00 | ≤ 3.0% CV | 10 | 5.006 | 1.12% | Pass |
| RBC | 4.50 to 5.50 | ≤ 1.5% CV | 10 | 4.67 | 0.51% | Pass |
| Hgb | 14.00 - 16.00 | ≤ 1.5% CV | 10 | 14.98 | 0.37% | Pass |
| MCV | 80.00 - 90.00 | ≤ 1.0% CV | 10 | 87.28 | 0.41% | Pass |
| RDW % | 12.00 - 14.00 | ≤ 2.5% CV | 10 | 13.47 | 0.98% | Pass |
| RDW-SD | 33.00 - 48.00 | ≤ 2.5% CV | 10 | 46.55 | 1.01% | Pass |
| Platelet | 200.00 - 400.00 | ≤ 3.5% CV | 10 | 252.5 | 1.37% | Pass |
| MPV | 8.00 - 10.00 | ≤ 2.5% CV | 10 | 8.66 | 1.15% | Pass |
| Neut % | 50.00 - 60.00 | ≤ 3.5% CV | 10 | 56.24 | 1.17% | Pass |
| Lymph % | 25.00 - 35.00 | ≤ 5.0% CV | 10 | 25.48 | 2.04% | Pass |
| Mono % | 5.00 - 10.00 | ≤ 10.0% CV | 10 | 7.61 | 5.71% | Pass |
| Eos % | 2.00 - 5.00 | ≤ 13.5% CV
or ≤ 0.5 SD | 10 | 2.58 | 6.64 % | Pass |
| Baso % | 0.50 - 1.50 | ≤ 0.5 SD | 10 | 0.95 | 0.23 SD | Pass |
| NRBC | 2.00 - 15.00 | ≤ 20% CV | 10 | 9.17 | 4.89% | Pass |
| NRBC | >15.00 | ≤ 15% CV | 10 | 19.49 | 1.49% | Pass |
| Retic % | 0.00 - 1.50 | ≤ 0.25 SD | 10 | 1.187 | 0.09 SD | Pass |
| IRF | ≥ 0.2 | ≤ 20% CV | 10 | 0.42 | 7.15% | Pass |
| MRV | 100.00 - 120.00 | ≤ 5.0% CV | 10 | 111.93 | 0.94% | Pass |

Repeatability DxH 900 Automatic CDR Mode

Repeatability DxH 690T Automatic CDR Mode

| Parameter | Level | Specification | N | Test Result
Mean | Test Result
%CV or
SD | Acceptance |
|-----------|-----------------|---------------|----|---------------------|-----------------------------|------------|
| WBC | 5.00 - 10.00 | ≤ 3.0% CV | 10 | 7.83 | 1.12% | Pass |
| RBC | 4.50 - 5.50 | ≤ 1.5% CV | 10 | 4.85 | 0.64% | Pass |
| Hgb | 14.00 - 16.00 | ≤ 1.5% CV | 10 | 15.30 | 0.41% | Pass |
| MCV | 80.00 - 90.00 | ≤ 1.0% CV | 10 | 86.18 | 0.38% | Pass |
| RDW % | 12.00 - 14.00 | ≤ 2.5% CV | 10 | 13.68 | 0.87 | Pass |
| RDW-SD | 33.00 - 48.00 | ≤ 2.5% CV | 10 | 46.77 | 1.68% | Pass |
| Platelet | 200.00 - 400.00 | ≤ 3.5% CV | 10 | 230.8 | 1.17% | Pass |

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| Parameter | Level | Specification | N | Test Result
Mean | Test Result
%CV or
SD | Acceptance |
|-----------|---------------|---------------------------|----|---------------------|-----------------------------|------------|
| MPV | 8.00 - 10.00 | ≤ 2.5% CV | 10 | 8.69 | 0.83% | Pass |
| Neut % | 50.00 - 60.00 | ≤ 3.5% CV | 10 | 54.70 | 1.46% | Pass |
| Lymph % | 25.00 - 35.00 | ≤ 5.0% CV | 10 | 27.39 | 2.61% | Pass |
| Mono % | 5.00 - 10.00 | ≤ 10.0% CV | 10 | 5.85 | 5.10% | Pass |
| Eos % | 2.00 - 5.00 | ≤ 13.5% CV
or ≤ 0.5 SD | 10 | 2.13 | 8.14% | Pass |
| Baso % | 0.50 - 1.50 | ≤ 0.5 SD | 10 | 0.83 | 0.24 SD | Pass |
| NRBC | 2.00 - 15.00 | ≤ 20% CV | 10 | 8.93 | 4.38% | Pass |
| NRBC | > 15.00 | ≤ 15% CV | 10 | 18.86 | 3.02% | Pass |
| Retic % | 0.00 - 1.50 | ≤ 0.25 SD | 10 | 1.22 | 0.13 SD | Pass |
| IRF | ≥ 0.20 | ≤ 20% CV | 10 | 0.35 | 7.29% | Pass |
| MRV | 100.0-120.0 | ≤ 5.0% CV | 10 | 109.77 | 1.20% | Pass |

Linearity using COULTER LIN-X Linearity Controls - Linearity was performed O in the CBC test panel for WBC, RBC, Hgb and PLT using LIN-X Linearity Control. Linearity with the COULTER LIN-X Linearity Control was performed on the DxH 900 and DxH 690T test instruments. LIN-X Linearity Control passed for all data points on both test instruments.

DxH 900 WBC Linearity

Image /page/30/Figure/3 description: The image shows a linearity plot of the test Wbc (BA51011,4/16/2019,Barracuda). The plot has assay values on the x-axis and values ranging from 81.8 to 413 on the y-axis. There are 6 data points on the plot, labeled as Level 1 through Level 6. The data points appear to follow a linear trend.

DxH 900 Hgb Linearity

Image /page/30/Figure/5 description: The image is a linearity plot of the test Hgb (BA51011,4/16/2019,Barracuda). The x-axis is labeled as 'Assay Values' and ranges from -1 to 27. The y-axis is labeled as 'Mean of aspirations per level' and ranges from -1 to 27. There is a linear trendline plotted on the graph.

DxH 900 RBC Linearity

Image /page/30/Figure/7 description: The image is a linearity plot of the test Rbc (BA51011,4/16/2019, Barracuda). The x-axis is labeled as "Assay Values", and the y-axis is labeled as "Mean of aspirations per level". The plot shows a linear relationship between the assay values and the mean of aspirations per level. There are 6 data points on the plot.

DxH 900 PLT Linearity

Image /page/30/Figure/9 description: The image is a linearity plot of the test pit (BA51011, 4/16/2019, Barracuda). The x-axis represents the assay values, ranging from -3 to 5074. The y-axis represents the mean of aspirations per level, also ranging from -3 to 5074. There are data points plotted on the graph, labeled as Level 2, Level 4, Level 6, Level 8, and Level 10.

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DxH 690T WBC Linearity

Image /page/31/Figure/1 description: The image is a linearity plot of the test Wbc (BC09306,4/16/2019, Barracuda). The plot shows the mean of aspirations per level on the y-axis and assay values on the x-axis. There are several data points plotted on the graph, and a linear trend line is drawn through the data points. The plot also includes a confidence interval around the trend line.

Image /page/31/Figure/2 description: The image shows the text "DxH 690T Hgb Linearity". The text is in bold, black font. The text appears to be the title of a document or presentation.

DxH 690T RBC Linearity

Image /page/31/Figure/4 description: The image is a linearity plot of the test Rbc (BC09305,4/16/2019, Barracuda). The plot shows the relationship between the mean of aspirations per level and assay values. There are 5 data points on the plot, and they appear to be linearly related. The data points are labeled as Level 1, Level 2, Level 3, Level 4, and Level 5.

DxH 690T PLT Linearity

Image /page/31/Figure/6 description: The image contains two plots titled "Linearity Plot of the Test Hgb (BC09305,4/16/2019 Barracuda)" and "Linearity Plot of the Test Pit (BC09305,4/16/2019.Barracuda)". Both plots show a linear relationship between Assay Values and Mean of aspirations per level. The plots include a line of best fit and confidence intervals.

Accuracy A total of 382 whole blood specimens (60 normal, 322 abnormal) O were collected. Accuracy testing was performed in the automatic mode using the CDR test panel by analyzing each blood sample once through the DxH 900 and DxH 690T instruments and the DxH 800 (predicate). COULTER S-Cal Calibrator was analyzed on the test and comparator instruments each day of accuracy testing if zero calibration was required. Results for CBC, Differential, NRBC, RET, IRF, and MRV parameters were compared using the specifications of the DxH 800. Weighted Deming analysis was performed for WBC, RBC, and PLT, and Deming analysis was performed for the WBC Differential, RETIC, IRF, and MRV parameters, and the remaining CBC parameters. The average bias and upper and lower limits of bias for the complete data set, 25th, 50th, 75th percentiles, and medical decision points were compared to the DxH 800 accuracy specifications for each parameter. Although the COULTER S-Cal Calibrator was analyzed every day of testing, no adjustments were required. Regression analysis was performed for NRBC to obtain the coefficient of variation to compare to the DxH 800 specification. Parameters results with "R" flags, had non-numeric, or partial aspiration were excluded from the analysis.
The CBC, WBC Differential, MRV, RET, IRF, and NRBC results for accuracy met the DxH 800 accuracy specifications for the DxH 900 and DxH 690T instruments. Mean difference and average lower and upper bias statistics for the CBC, WBC differential, MRV and IRF parameter comparisons follow. The acceptance limit was calculated from the DxH 800 accuracy specification. Results for the 25th, 50th and 75th percentiles and medical decision levels are not shown, but all recovered within the accuracy specification.

32

| Parameter | N | Clinical Range | Mean
Comp. | Mean
Test | Mean
Diff | Lower
Bias | Upper
Bias | Acc.*
Limit |
|------------|-----|----------------|---------------|--------------|--------------|---------------|---------------|----------------|
| WBC | 376 | 0.06 - 148.83 | 9.88 | 9.82 | -0.07 | -0.10 | -0.04 | ± 0.20 |
| RBC | 376 | 1.68 - 8.49 | 3.84 | 3.84 | 0.01 | 0.00 | 0.01 | ± 0.07 |
| Hgb | 374 | 4.95 -24.84 | 11.12 | 11.10 | -0.02 | -0.03 | -0.01 | ± 0.3 |
| MCV | 374 | 66.15 -115.06 | 88.05 | 87.66 | -0.39 | -0.43 | -0.34 | ± 1.7 |
| RDW | 374 | 11.93 - 27.60 | 16.52 | 16.46 | -0.06 | -0.09 | -0.03 | ± 0.80 |
| RDW-SD | 374 | 35.88 - 92.31 | 50.94 | 51.08 | 0.14 | 0.02 | 0.25 | ± 5.00 |
| PLT | 338 | 7.80 -788.70 | 230.05 | 224.93 | -5.12 | -5.97 | -4.27 | ± 16.10 |
| MPV | 338 | 6.58-12.21 | 8.73 | 8.90 | 0.17 | 0.15 | 0.19 | ± 0.60 |
| Neutrophil | 346 | 0.66-96.2 | 64.26 | 63.98 | -0.28 | -0.39 | -0.18 | ± 6.40 |
| Lymphocyte | 346 | 1.03-98 | 23.01 | 23.42 | 0.41 | 0.31 | 0.51 | ± 2.30 |
| Monocyte | 346 | 0.00-92.73 | 9.81 | 9.67 | -0.15 | -0.23 | -0.07 | ± 1.00 |
| Eosinophil | 346 | 0.00 - 20.30 | 2.31 | 2.30 | 0.00 | -0.03 | 0.02 | ± 0.50 |
| Basophil | 346 | 0.00 - 3.61 | 0.61 | 0.63 | 0.02 | -0.01 | 0.06 | ± 0.50 |
| RET | 374 | 0.03-15.20 | 1.81 | 1.82 | 0.01 | -0.01 | 0.03 | ± 0.50 |
| MRV | 374 | 76.42-170.24 | 117.49 | 117.28 | -0.22 | -0.61 | 0.18 | ± 15.00 |
| IRF | 374 | 0.00-0.77 | 0.45 | 0.44 | 0.00 | -0.01 | 0.00 | ± 0.20 |

Mean Difference/Bias Statistics DxH 900 vs DxH 800 (predicate)

= Acceptance limit calculated from Deming Regression analysis

Mean Difference/Bias Statistics DxH 690T vs DxH 800 (predicate)

| Parameter | N | Clinical Range | Mean
Comp. | Mean
Test | Mean
Diff | Lower
Bias | Upper
Bias | Acc.*
Limit |
|------------|-----|----------------|---------------|--------------|--------------|---------------|---------------|----------------|
| WBC | 368 | 0.06 - 148.83 | 9.86 | 9.82 | -0.04 | -0.08 | 0.01 | $\pm$ 0.20 |
| RBC | 369 | 1.68 - 8.49 | 3.85 | 3.84 | -0.01 | -0.02 | -0.01 | $\pm$ 0.07 |
| Hgb | 367 | 4.95 -24.84 | 11.16 | 11.13 | -0.03 | -0.05 | -0.02 | $\pm$ 0.30 |
| MCV | 367 | 66.15 -115.06 | 87.99 | 87.71 | -0.28 | -0.32 | -0.23 | $\pm$ 1.70 |
| RDW | 367 | 11.93 - 27.60 | 16.51 | 16.49 | -0.02 | -0.04 | 0.01 | $\pm$ 0.80 |
| RDW-SD | 367 | 35.88 - 92.31 | 50.88 | 51.15 | 0.26 | 0.15 | 0.37 | $\pm$ 5.00 |
| PLT | 334 | 7.80 -788.70 | 230.45 | 231.48 | 1.03 | 0.25 | 1.81 | $\pm$ 16.10 |
| MPV | 335 | 6.58-12.21 | 8.73 | 8.68 | -0.06 | -0.09 | -0.03 | $\pm$ 0.60 |
| Neutrophil | 340 | 0.66-96.2 | 64.69 | 64.42 | -0.27 | -0.38 | -0.16 | $\pm$ 6.40 |
| Lymphocyte | 340 | 1.03-98 | 22.56 | 22.94 | 0.38 | 0.28 | 0.47 | $\pm$ 2.20 |
| Monocyte | 340 | 0.00-92.73 | 9.79 | 9.68 | -0.11 | -0.20 | -0.02 | $\pm$ 1.00 |
| Eosinophil | 340 | 0.00 - 20.30 | 2.34 | 2.34 | -0.01 | -0.04 | 0.02 | $\pm$ 0.50 |
| Basophil | 340 | 0.00 - 3.61 | 0.61 | 0.63 | 0.02 | -0.03 | 0.07 | $\pm$ 0.50 |
| RET | 371 | 0.03-15.20 | 1.78 | 1.90 | 0.12 | 0.09 | 0.15 | $\pm$ 0.50 |
| MRV | 371 | 76.42-170.24 | 117.27 | 117.09 | -0.17 | -0.59 | 0.25 | $\pm$ 15.0 |
| IRF | 371 | 0.00-0.77 | 0.44 | 0.44 | -0.01 | -0.01 | 0.00 | $\pm$ 0.20 |

= Acceptance limit calculated from Deming Regression analysis

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| Parameter | Unit | Slope | 95% Confidence Limits | | Intercept | 95% Confidence
Limits | | Correlation | 95% Confidence
Limits | |
|--------------|----------------|-------|-----------------------|-------|-----------|--------------------------|--------|-------------|--------------------------|---------|
| | | | Lower | Upper | | Lower | Upper | | Lower | Upper |
| WBC | x 103 cells/µL | 0.994 | 0.991 | 0.996 | -0.002 | -0.004 | 0.000 | 0.99969 | 0.99962 | 0.99974 |
| RBC | x 106 cells/µL | 1.013 | 1.010 | 1.017 | -0.042 | -0.054 | -0.030 | 0.99955 | 0.99945 | 0.99963 |
| Hemoglobin | g/dL | 0.989 | 0.986 | 0.993 | 0.101 | 0.061 | 0.141 | 0.99957 | 0.99947 | 0.99965 |
| MCV | fL | 0.995 | 0.988 | 1.003 | 0.020 | -0.623 | 0.663 | 0.99798 | 0.99752 | 0.99835 |
| RDW | % | 0.999 | 0.987 | 1.012 | -0.042 | -0.235 | 0.152 | 0.9954 | 0.99437 | 0.99625 |
| RDW-SD | fL | 1.005 | 0.988 | 1.022 | -0.120 | -0.947 | 0.707 | 0.99395 | 0.99259 | 0.99506 |
| Platelet | x 103 cells/µL | 0.979 | 0.974 | 0.983 | -0.456 | -0.994 | 0.082 | 0.99896 | 0.99872 | 0.99916 |
| MPV | fL | 1.019 | 0.995 | 1.043 | 0.009 | -0.190 | 0.209 | 0.98282 | 0.97875 | 0.98611 |
| Neutrophil | % | 1.001 | 0.995 | 1.007 | -0.347 | -0.753 | 0.059 | 0.99878 | 0.99849 | 0.99901 |
| Lymphocyte | % | 1.007 | 0.998 | 1.015 | 0.258 | 0.085 | 0.431 | 0.99855 | 0.9982 | 0.99882 |
| Monocyte | % | 0.989 | 0.965 | 1.012 | -0.036 | -0.238 | 0.166 | 0.99703 | 0.99633 | 0.9976 |
| Eosinophil | % | 0.997 | 0.982 | 1.012 | 0.003 | -0.028 | 0.034 | 0.99617 | 0.99527 | 0.9969 |
| Basophil | % | 0.964 | 0.604 | 1.323 | 0.045 | -0.148 | 0.238 | 0.6141 | 0.54388 | 0.67578 |
| Reticulocyte | % | 0.987 | 0.949 | 1.026 | 0.033 | -0.027 | 0.093 | 0.9916 | 0.98971 | 0.99314 |
| MRV | fL | 0.989 | 0.960 | 1.019 | 1.051 | -2.508 | 4.610 | 0.96892 | 0.96204 | 0.97457 |
| IRF | % | 0.960 | 0.911 | 1.008 | 0.016 | -0.009 | 0.040 | 0.92773 | 0.91213 | 0.94064 |

Regression Statistics and Correlation for DxH 900 (Test) vs DxH 800 (Predicate)

Regression Statistics and Correlation for DxH 690T (Test) vs DxH 800 (Predicate)

Parameter			95% Confidence Limits			95% Confidence Limits		Correlation	95% Confidence Limits
	Unit	Slope	Lower	Upper	Intercept	Lower	Upper		Lower	Upper
WBC	x 103 cells/µL	0.994	0.992	0.997	0.000	-0.002	0.002	0.99945	0.99932	0.99955
RBC	x 106 cells/µL	1.008	1.004	1.012	-0.039	-0.053	-0.025	0.99955	0.99944	0.99963
Hemoglobin	g/dL	0.985	0.982	0.989	0.130	0.092	0.168	0.99955	0.99945	0.99964
MCV	fL	1.001	0.994	1.008	-0.342	-0.950	0.267	0.99784	0.99735	0.99824
RDW	%	1.003	0.991	1.016	-0.072	-0.269	0.124	0.99593	0.99500	0.99668
RDW-SD	fL	1.017	1.001	1.034	-0.627	-1.411	0.158	0.99460	0.99338	0.99560
Platelet	x 103 cells/µL	1.012	1.001	1.024	-0.854	-2.236	0.527	0.99901	0.99878	0.99920
MPV	fL	0.995	0.970	1.020	-0.015	-0.227	0.196	0.96869	0.96132	0.97468
Neutrophil	%	1.002	0.996	1.009	-0.428	-0.832	-0.023	0.99862	0.99829	0.99889
Lymphocyte	%	1.012	1.004	1.020	0.117	-0.065	0.298	0.99854	0.99819	0.99882
Monocyte	%	0.972	0.959	0.986	0.158	0.025	0.290	0.99647	0.99564	0.99715
Eosinophil	%	0.992	0.972	1.012	0.011	-0.029	0.050	0.99526	0.99413	0.99617
Basophil	%	1.481	0.383	2.579	-0.275	-0.275	-0.275	0.47300	0.38606	0.55161
Reticulocyte	%	1.031	0.987	1.074	0.062	-0.004	0.129	0.98788	0.98515	0.99011
MRV	fL	0.996	0.961	1.030	0.349	-3.792	4.491	0.96512	0.95738	0.97148
IRF	%	1.018	0.971	1.065	-0.014	-0.038	0.009	0.92436	0.90801	0.93791

34

Carryover Within mode carryover was performed in the automatic CDR mode using o the customer "Carryover" application in the software. Normal whole blood, clinical samples, and blood altered by concentration, or the addition of analogs were used to achieve the following levels for testing:
- WBC > 90.0
- WBC > 300
- ≫ RBC > 6.20
- ≫ Hgb > 22.0
- PLT > 900

Carryover was performed on the DxH 690T and DxH 900. Carryover results for both test instruments recovered within the DxH 800 carryover limits.

Carryover WBC > 90

| CnDR

Mode	WBC	RBC	Hgb	PLT	Diff	NRBC	Retic
DxH 690T	0.11%	0.03%	0.26%	0.07%	22, 20, 35	12, 5, 7	25, 20, 22
DxH 900	0.09%	0.05%	0.23%	0.17%	11,15,37	7,1,3	10,6,3
Spec	300

| CnDR

Mode	WBC	RBC	Hgb	PLT	Diff	NRBC	Retic
DxH 690T	0.18%	0.04%	0.18%	0.02%	42, 36, 16	24, 12,10	27, 20, 25
DxH 900	0.13%	0.05%	0.13%	0.06%	31, 29, 28	15, 4, 1	19, 6, 7
Spec	≤0.5%	≤0.5%	≤1.0%	≤1.0%	≤200 Events	≤100 Events	≤600 Events

Carryover RBC > 6.20

| CnDR

Mode	WBC	RBC	Hgb	PLT	Diff	NRBC	Retic
DxH 690T	0.25%	0.03%	0.30%	0.12%	25, 15, 24	12, 16, 9	23, 15, 16
DxH 900	0.22%	0.04%	0.16%	-0.03%	30, 14, 39	11, 2, 1	27, 8, 11
Spec	≤0.5%	≤0.5%	≤1.0%	≤1.0%	≤200 Events	≤75 Events	≤600 Events

Carryover Hgb > 22.0

| CnDR

Mode	WBC	RBC	Hgb	PLT	Diff	NRBC	Retic
DxH 690T	0.20%	0.03%	0.17%	0.03%	31, 16, 15	9, 3, 6	44, 9, 4
DxH 900	0.19%	0.03%	0.17%	-0.23%	14, 37, 28	1, 5, 3	37, 8, 3
Spec	≤0.5%	≤0.5%	≤1.0%	≤1.0%	≤200 Events	≤75 Events	≤600 Events

35

Carryover Platelet > 900

| CnDR

Mode	WBC	RBC	Hgb	PLT	Diff	NRBC	Retic
DxH 690T	0.15%	0.03%	0.13%	0.10%	22, 15, 14	11, 5, 8	12, 15, 11
DxH 900	0.13%	0.05%	0.22%	0.09%	31, 26, 23	2, 2, 3	16, 13, 13
Spec	≤0.5%	≤0.5%	≤1.0%	≤1.0%	≤200 Events	≤75 Events	≤600 Events

807.92 (b)(3): Conclusions from Analytical and Performance Data

All data provided for the nonclinical and clinical testing demonstrates that the UniCel DxH 900/DxH 690T Coulter Cellular Analysis System (DxH 900, DxH 690T) and the UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System (SMS II) are as safe, as effective, and perform as well as or better than the UniCel DxH 800 Coulter Cellular Analysis System (DxH 800) and the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System (SMS).