K Number
K230887
Device Name
Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
Date Cleared
2023-12-21

(265 days)

Product Code
Regulation Number
864.5220
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.
Device Description
The Sysmex XQ-Series (XQ-320) automated hematology analyzer is a multi-parameter hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates whole blood parameters by DC (Direct Current) detection method and non-cyanide HGB analysis method (Colorimetric method) on whole blood samples collected in K2 or K3EDTA anticoagulant. The XQ-320 analyzer consists of one unit which aspirates and dispenses diluent to prepare blood dilutions and analyzes whole blood samples. The operator must mix the sample manually then introduce the sample tube to the aspiration pipette with the cap off, and presses the start switch to execute aspiration and analysis. The XQ-320 analyzer uses a built-in monitor to operate the analyzer and process data.
More Information

No
The document describes a standard automated hematology analyzer using established detection methods (DC and Colorimetric). There is no mention of AI, ML, image processing, or any training/test sets related to algorithmic learning. The performance studies are standard for this type of device and do not indicate the use of AI/ML for analysis or interpretation.

No
Explanation: This device is an in vitro diagnostic (IVD) hematology analyzer used for screening and enumerating blood parameters, which falls under diagnostic purposes rather than directly treating a disease or condition.

Yes

The "Intended Use / Indications for Use" section explicitly states that "The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories."

No

The device description explicitly states it is a "multi-parameter automated hematology analyzer" that "consists of one unit which aspirates and dispenses diluent to prepare blood dilutions and analyzes whole blood samples." This indicates the presence of physical hardware components beyond just software.

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

Here's why:

  • Explicit Statement in Intended Use/Indications for Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories."
  • Explicit Statement in Device Description: The "Device Description" section also reiterates this: "The Sysmex XQ-Series (XQ-320) automated hematology analyzer is a multi-parameter hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories."
  • Nature of the Device: The device analyzes whole blood samples to classify and enumerate various hematology parameters (WBC, RBC, HGB, etc.). This type of analysis is performed on biological samples outside of the body to provide information for the diagnosis, treatment, or prevention of disease, which is the definition of an in vitro diagnostic device.
  • Intended User and Setting: The intended user is clinical laboratories, and the intended use is for screening patient populations. This aligns with the typical use of IVD devices.

N/A

Intended Use / Indications for Use

The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.

Product codes

GKZ

Device Description

The Sysmex XQ-Series (XQ-320) automated hematology analyzer is a multi-parameter hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates whole blood parameters by DC (Direct Current) detection method and non-cyanide HGB analysis method (Colorimetric method) on whole blood samples collected in K2 or K3EDTA anticoagulant. The XQ-320 analyzer consists of one unit which aspirates and dispenses diluent to prepare blood dilutions and analyzes whole blood samples. The operator must mix the sample manually then introduce the sample tube to the aspiration pipette with the cap off, and presses the start switch to execute aspiration and analysis. The XQ-320 analyzer uses a built-in monitor to operate the analyzer and process data.

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

pediatrics (21 years) donors.
Annotation protocol: Each sample was run in singlet within 8 hours of collection.

Venous Whole Blood vs. Capillary Whole Blood (K2EDTA):
Sample size: forty-two paired venous whole blood and capillary whole blood samples (K2EDTA).
Data source: consented adult (>21 years) donors.
Annotation protocol: Each sample was run in singlet within 8 hours of collection.

Whole Blood K2EDTA Normal Tubes vs. Micro-collection Tube:
Sample size: 183 residual K2EDTA (4 mL tubes) whole blood samples.
Data source: Not explicitly stated.
Annotation protocol: Whole blood K2EDTA normal tubes were premixed and run in singlet. Within two hours of analysis of the K2EDTA normal tubes, the samples were remixed, then transferred to micro-collection tubes without anticoagulant additive, then analyzed in singlet.

Whole Blood K2EDTA Mode vs. Pre-dilute Mode:
Sample size: 35 residual K2EDTA anticoagulated whole blood samples.
Data source: Not explicitly stated.
Annotation protocol: K2EDTA whole blood samples were premixed then run in the whole blood mode with caps off. A 1:7 predilute sample was prepared for each whole blood sample by adding 120 µL of system diluent (CELLPACK) and 20 uL of whole blood into plain micro-collection tubes. The prediluted samples were thoroughly mixed and run in the predilute mode of the XQ-320 analyzer with caps off.

Reference Intervals:
Sample size: 99 unique male and female (43 male and 56 female) whole blood samples for adults; 226 pediatric subjects (34 neonates, 63 infants, 63 children, 66 adolescents).
Data source: generally healthy, consenting donors (>21 years of age for adults); pediatric samples enrolled in the method comparison study.
Annotation protocol: Verification conducted according to CLSI EP28-A3c. For adults, results reported as 'Negative' judgment (without flags) from apparently normal, healthy subjects in the method comparison study were compared to previously established reference intervals. For pediatrics, results were compared to literature reference intervals.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Method Comparison
Study type: Method Comparison
Sample size: 628 unique residual and prospectively collected venous whole blood samples
Key results:
WBC: Correlation Coefficient 0.9994, Slope 0.992, Y Intercept 0.215
RBC: Correlation Coefficient 0.9984, Slope 0.970, Y Intercept 0.107
HGB: Correlation Coefficient 0.9987, Slope 0.974, Y Intercept 0.45
HCT: Correlation Coefficient 0.9965, Slope 0.964, Y Intercept 0.62
MCV: Correlation Coefficient 0.9881, Slope 1.005, Y Intercept -1.98
MCH: Correlation Coefficient 0.9861, Slope 0.997, Y Intercept 0.57
MCHC: Correlation Coefficient 0.8914, Slope 0.880, Y Intercept 4.83
PLT: Correlation Coefficient 0.9960, Slope 0.989, Y Intercept -1.9
RDWSD: Correlation Coefficient 0.9467, Slope 1.028, Y Intercept -5.03
RDWCV: Correlation Coefficient 0.9645, Slope 1.167, Y Intercept -3.15
MPV: Correlation Coefficient 0.9027, Slope 0.912, Y Intercept 0.40
NEUT#: Correlation Coefficient 0.9959, Slope 1.020, Y Intercept -0.176
Lymph#: Correlation Coefficient 0.9962, Slope 1.012, Y Intercept 0.109
MXD#: Correlation Coefficient 0.8525, Slope 1.280, Y Intercept -0.247
NEUT%: Correlation Coefficient 0.9600, Slope 1.017, Y Intercept -2.32
LYMPH%: Correlation Coefficient 0.9827, Slope 1.031, Y Intercept 0.18
MXD%: Correlation Coefficient 0.5933, Slope 1.415, Y Intercept -4.25

Sensitivity and Specificity
Study type: Clinical sensitivity/specificity (estimates of agreement)
Key results:
Three External Clinical Sites:
Any Abnormal Distributional Flag: Sensitivity 89.5% (95% CI 83.29, 94.01), Specificity 75.5% (95% CI 65.58, 83.81), Overall % Agreement 84.0% (95% CI 78.66, 88.40)
Any Abnormal Morphological Flag: Sensitivity 74.5% (95% CI 67.08, 81.06), Specificity 76.0% (95% CI 69.37, 81.89), Overall % Agreement 75.4% (95% CI 70.52, 79.76)
Any Abnormal Distributional and/or Abnormal Morphological Flag: Sensitivity 90.7% (95% CI 86.36, 94.01), Specificity 56.6% (95% CI 46.99, 65.93), Overall % Agreement 80.0% (95% CI 75.49, 84.01)
One Internal Site:
Any Abnormal Distributional Flag: Sensitivity 91.4% (95% CI 83.00, 96.45), Specificity 92.4% (95% CI 86.13, 96.48), Overall % Agreement 92.0% (95% CI 87.33, 95.36)
Any Abnormal Morphological Flag: Sensitivity 28.2% (95% CI 15.00, 44.87), Specificity 94.0% (95% CI 88.92, 97.22), Overall % Agreement 80.4% (95% CI 74.04, 85.83)
Any Abnormal Distributional and/or Abnormal Morphological Flag: Sensitivity 83.5% (95% CI 74.27, 90.47), Specificity 91.7% (95% CI 84.90, 96.15), Overall % Agreement 88.0% (95% CI 82.67, 92.16)

Precision (Repeatability)
Study type: Repeatability
Key results: All pooled results met the predefined acceptance criteria and were determined to be acceptable. (Detailed table provided in document).

Reproducibility
Study type: Reproducibility
Key results: All results met the predefined acceptance criteria and were determined to be acceptable. (Detailed table provided in document).

Linearity
Study type: Linearity
Key results: All results met the predefined acceptance criteria and were determined to be acceptable.

Carryover
Study type: Carryover
Key results: All results were determined to be acceptable.

Interfering Substances Study
Study type: Interfering Substances
Key results: All results met the predefined acceptance criteria and were determined to be acceptable.

Limits of Blank, Detection, and Quantitation (LoB, LoD, and LoQ)
Study type: Limits of Blank, Detection, and Quantitation
Key results: The LoB, LoD and LoQ results met the manufacturer's specifications.

Sample Stability
Study type: Sample Stability
Key results: Whole blood sample stability supports storage condition: 12 hours at room temperature (18-26°C) and 24 hours at refrigerated temperature (2-8°C) provided in the instructions for use labeling.

Anticoagulant Comparability (K2EDTA vs. K3EDTA)
Study type: Anticoagulant Comparability
Key results: The results of the regression analysis and bias estimates between K2EDTA and K3EDTA anticoagulated whole blood samples met the acceptance criteria.

Venous Whole Blood vs. Capillary Whole Blood (K2EDTA)
Study type: Comparability
Key results: The results of the regression analysis and bias estimates between venous and capillary K2EDTA whole blood samples met acceptance criteria.

Whole Blood K2EDTA Normal Tubes vs. Micro-collection Tube
Study type: Comparability
Key results: The results of the regression analysis and bias estimates between the whole blood normal K2EDTA to micro-tube comparison samples met acceptance criteria.

Whole Blood K2EDTA Mode vs. Pre-dilute Mode
Study type: Comparability
Key results: The results of the regression analysis and bias estimates between the whole blood and predilute mode samples met acceptance criteria.

Reference Intervals
Study type: Verification of adult and pediatric reference intervals
Key results: Reference intervals for adults were determined to be acceptable if the proposed reference intervals overlapped the 95% confidence intervals (lower and upper limit) of the dataset. Results from 226 pediatric subjects were compared to literature reference intervals for acceptable use with the XQ-320.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

See "Summary of Performance Studies" section for detailed metrics.

Predicate Device(s)

K112605

Reference Device(s)

K032677

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.”

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December 21, 2023

Sysmex America, Inc. Yvonne Doswell Sr. Scientist, Regulatory Affairs 577 Aptakisic Road Lincolnshire, Illinois 60069

Re: K230887

Trade/Device Name: Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: March 30, 2023 Received: March 31, 2023

Dear Yvonne Doswell:

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. 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).

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Your device is also subject to, among other requirements, the Quality System (QS) 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 OS 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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,

Min Wu-S

Min Wu, Ph.D. 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

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Indications for Use

510(k) Number (if known) K230887

Device Name

Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer

Indications for Use (Describe)

The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.

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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5. 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.

Submitter's name, address, telephone number, a contact person, and date the summary was prepared:

Submitter's Name:Sysmex America, Inc.
Submitter's Address:577 Aptakisic Road
Lincolnshire, IL 60069
Submitter's Contact:Yvonne Doswell
Senior Scientist, Regulatory Affairs
E-Mail: doswelly@sysmex.com
Phone: (678) 274-8024

Date 510(k) Summary Prepared: December 21, 2023

Name of the device, including the trade or proprietary name, the common or usual name, and the classification name:

Proprietary Name:Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
Common Name:Automated Hematology Analyzer
Classification Name:Automated Differential Cell Counter
Regulation Description:Automated Differential Cell Counter
Regulation Section:21 CFR 864.5220
Device Class:2
Product Code:GKZ

Related Reagents, Controls and Calibrator:

Product Code: 81GIF CELLPACK (Diluent)

Product Code: 81GGK STROMATOLYSER-WH (Lyse)

Product Code: 81KSA SCS-1000 (Calibrator)

Product Code: 81PPM CELLCLEAN (Cleaning solution)

Product Code: 81JPK EIGHTCHECK-3WP X-TRA (3 Controls)

Predicate Device and 510(k) number: Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer, K112605

Description of the Device:

The Sysmex XQ-Series (XQ-320) automated hematology analyzer is a multi-parameter hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates whole blood parameters by DC (Direct Current) detection method and non-cyanide HGB analysis method (Colorimetric

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method) on whole blood samples collected in K2 or K3EDTA anticoagulant. The XQ-320 analyzer consists of one unit which aspirates and dispenses diluent to prepare blood dilutions and analyzes whole blood samples. The operator must mix the sample manually then introduce the sample tube to the aspiration pipette with the cap off, and presses the start switch to execute aspiration and analysis. The XQ-320 analyzer uses a built-in monitor to operate the analyzer and process data.

Statement of Intended Use:

The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.

Summary of Comparison of Technological Characteristics:

Table 5-1 compares the similarities and differences between the Sysmex XQ-320 Automated Hematology analyzer with the predicate XN-10 Automated Hematology analyzer.

| | Predicate Device:
XN-Series (XN-10)
K112605 | Subject Device:
XQ-Series (XQ-320) | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Item | Device Similarities | | |
| | The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. | The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. | |
| | The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, IRF, RET-He and has a Body Fluid mode for body fluids.
The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/# and TC-BF parameters in | The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#. | |
| Intended Use | | | |
| | | cerebrospinal fluid (CSF), serous
fluids (peritoneal, pleural) and
synovial fluids. Whole blood should
be collected in K2 or K3EDTA
anticoagulant and, Serous and
Synovial fluids in K2EDTA
anticoagulant to prevent clotting of
fluid. The use of anticoagulants
with CSF specimens is neither
required nor recommended. | |
| Specimen Type | Whole Blood collected in K2 or
K3EDTA | SAME | |
| Test Principle | Performs hematology analyses using
DC Detection | SAME | |
| Parameters | Whole Blood Mode:
WBC, RBC, HGB, HCT, MCV,
MCH, MCHC, PLT, NEUT%/#,
LYMPH%/#, RDW-CV, RDW-SD,
MPV | SAME | |
| Analysis Modes | Manual Analysis Mode
[Whole Blood] mode
[Pre-Dilute] mode | SAME | |
| Sample
Aspiration/
Fluidic Pathway | Single Pathway | SAME | |
| Measuring
Channels | RBC/PLT, HGB | SAME | |
| | | | |
| Item | Predicate Device:
XN-Series (XN-10)
K112605 | Subject Device:
XQ-Series (XQ-320) | |
| Device Differences | | | |
| Specimen Type | Body Fluids Analysis Mode (CSF,
Peritoneal, Pleural, and Synovial
Fluids) | Not Available | |
| Test Principle | Flow cytometry method (using a
semiconductor laser) and SLS-
hemoglobin method. | DC detection method, Non-cyanide
hemoglobin analysis method | |
| Parameters | IG%/#, RET%/#, IPF, IRF, RET-He
PLT (PLT-F), NRBC%/#, WBC BF,
RBC-BF, MN%/#, PMN%/#, and
TC-BF | Not Available | |
| | MONO%/#, EO%/#, BASO%/# | MXD%/# (MONO+EO+BASO) | |
| | | | |
| Reagents | FLUOROCELL WNR (Stain)
FLUOROCELL WDF (Stain)
FLUOROCELL RET (Stain)
FLUOROCELL PLT (Stain) | Not Available | |
| | CELLPACK DFL (Diluent)
CELLPACK DCL (Diluent) | Not Available
CELLPACK (Diluent) | |
| | SULFOLYSER® (Lyse) | STROMATOLYSER-WH (Lyse) | |
| | LYSERCELL WNR (Lyse)
LYSERCELL WDF (Lyse) | | |
| | CELLCLEAN AUTO (Cleaning solution) | | |
| Measured
Channels | WNR, WPC, WDF, PLT-F, RET | Not Available | |
| WBC
Differential | 5-Part | 3-Part | |
| Controls/
Calibrators | Controls:
XN-Check -3 levels
XN Check BF - 2 levels | Controls:
EIGHTCHECK-3WP_X-TRA 3 levels | |
| | Calibrator:
XN CAL, XN CAL PF | Calibrator:
SCS-1000 | |
| | Sampler Analysis Mode:
Sample rack Sampler | Sampler Analysis Mode:
Not available | |
| Analysis Modes | Manual Analysis Mode:
[LWBC] Mode
Body Fluid Mode | Manual Analysis Mode:
Not Available | |
| | Whole Blood Mode: 100
samples/hour maximum depending
on mode used. | Whole Blood Mode:
Approximately 70 samples/hour | |
| | Pre-Dilution mode:
Approximately 90 samples/hour
maximum depending on mode used. | Pre-Dilution mode:
Approximately 60 samples/hour | |
| Throughput | Body Fluid Mode:
40 samples/hour | Body Fluid Mode:
Not Available | |
| | Sample
Aspiration
Volumes | Whole Blood Mode: 88 µL
Pre-Dilution Mode: 70 µL
Body Fluid Mode: 88 µL | |
| | Main Unit
Dimensions
(W x D x H | With Sampler (including the sampler
(SA-10) 645 x 755 x 855 | |

Table 5-1: Comparison of the Predicate XN-10 and the Subject XQ-Series (XQ-320) Automated Hematology Analyzers

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The XQ-320 analyzer Indications for Use statement is similar to the predicate device with minor differences. The XQ-320 analyzer also has similar technological characteristics as the predicate device with minor variation. Both devices measure similar parameters. The data collection and data management software functionality are similar to the predicate device with minor variation.

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The XO-320 analyzer differs from the predicate with a slower throughput and smaller sample aspiration volumes, fewer measuring channels, measurement of specimen types (i.e., body fluids), and fewer parameters measured, however it is very similar in fundamental scientific technology as the predicate device to establish equivalence. In addition. XO-320 control material and calibrator are specific for the XQ-320 analyzer. The XQ-320 analyzer performs a 3-part differential while the XN-10 performs a 5-part differential.

To demonstrate that differences in technological characteristics between the subject device and predicate device do not impact safety and effectiveness, the following clinical performance studies were conducted utilizing the XO-320 analyzer.

Summary of Performance Testing:

Clinical testing was conducted on the XQ-Series (XQ-320) analyzer to show equivalent performance to the XN-10 analyzer. Testing included:

Method Comparison

The method comparison study was conducted based on CLSI EP09c, 3rd edition at three (3) external US clinical sites and one (1) internal site to assess the performance of XQ-320 when compared to the predicate XN-10. A total of 628 unique residual and prospectively collected venous whole blood samples collected in K2EDTA anticoagulant from pediatrics (21 years) donors.

Each sample was run in singlet within 8 hours of collection. The results from the K2EDTA whole blood samples were compared to the corresponding results of the K3EDTA sample for the same donor.

The results of the regression analysis and bias estimates between K2EDTA and K3EDTA anticoagulated whole blood samples met the acceptance criteria.

Venous Whole Blood vs. Capillary Whole Blood (K2EDTA)

Comparability between venous whole blood and capillary whole blood samples on the XQ-320 analyzer was conducted using forty-two paired venous whole blood and capillary whole blood samples (K2EDTA) drawn from consented adult (>21 years) donors.

Each sample was run in singlet within 8 hours of collection. The venous whole blood sample results were compared to the corresponding results of the capillary sample for the same donor.

The results of the regression analysis and bias estimates between venous and capillary K2EDTA whole blood samples met acceptance criteria.

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Whole Blood K2EDTA Normal Tubes vs. Micro-collection Tube

K2EDTA tubes and micro-collection tubes without anticoagulant were performed to determine the presence or absence of matrix effect between the sample tubes on the XQ-320 analyzer.

This study used a total of 183 residual K2EDTA (4 mL tubes) whole blood samples with analyte concentrations representative of patient samples, across medical decision levels, and to the extent possible of the full analytical measuring range. Whole blood K2EDTA normal tubes were premixed and run in singlet. Within two hours of analysis of the K2EDTA normal tubes, the samples were remixed, then transferred to micro-collection tubes without anticoagulant additive, then analyzed in singlet.

The results from the K2EDTA whole blood samples were compared to the corresponding results of the micro-collection sample tube for the same patient sample. The results of the regression analysis and bias estimates between the whole blood normal K2EDTA to micro-tube comparison samples met acceptance criteria.

Whole Blood K2EDTA Mode vs. Pre-dilute Mode

Comparability between the whole blood and predilute mode on the XQ-320 analyzer was performed using 35 residual K2EDTA anticoagulated whole blood samples. The K2EDTA whole blood samples were premixed from end to end by gentle inversion, then run in the whole blood mode with caps off. Following the analysis of the whole blood samples, a 1:7 predilute sample was prepared for each whole blood sample by adding 120 µL of system diluent (CELLPACK) and 20 uL of whole blood into plain micro-collection tubes. The prediluted samples were thoroughly mixed by gentle inversion and run in the predilute mode of the XQ-320 analyzer with caps off. The results from the predilute mode are automatically multiplied by 7 before results are displayed, therefore no additional calculation is required. The results from the K2EDTA whole blood samples were compared to the corresponding results of the prediluted sample for the same patient sample. The results of the regression analysis and bias estimates between the whole blood and predilute mode samples met acceptance criteria.

Reference Intervals

Verification of adult and pediatric reference intervals was conducted on the XQ-320 analyzer to demonstrate comparability of whole blood reference intervals for an adult population (>21 years) to the ranges established for the Sysmex pocH-100i (K032677) and pediatric population (birth to 21 years of age to verify normal reference ranges.

Reference intervals for adults were determined to be acceptable if the proposed reference intervals overlapped the 95% confidence intervals (lower and upper limit) of the dataset.

The results from 226 pediatric subjects including each pediatric subpopulations: 34 neonates (birth-1 month); 63 infants (>1 month-2 years); 63 children (>2 years-12 years); and 66 adolescents (>12 years-21 years) were compared to literature reference intervals.

Conclusions:

The XQ-Series (XQ-320) Automated Hematology analyzer and its predicate device, XN-10 Automated Hematology analyzer (K112605), have similar Indications for Use, fundamental technology, and principles of operation. Performance, verification, and validation testing were conducted to characterize the performance of the XQ-320 analyzer using predetermined acceptance criteria. Results of this testing have documented that the XQ-320 analyzer is substantially equivalent to the XN-10 analyzer. The differences in the XQ-320 analyzer and the predicate device (XN-10 analyzer) do not raise any questions regarding safety and effectiveness.