The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System are quantitative automated hematology analyzers for in vitro diagnostic use in clinical laboratories. The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System provide complete blood count, (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV) and Leukocyte 3-Part Differential [LY (%/#), MO (%/#), GR (%/#)] for whole blood specimens, collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained by venipuncture, heel or fingerstick. The purpose of the DxH 300 and the DxH 300C is to identify normal human patients, with normal system-generated parameters, from patients whose results require additional studies.

Device Description

The DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis Analyzers are intended for In Vitro Diagnostic clinical laboratories. The DxH 300C has the capability to process samples in an fferentials pos of the DxH 300 Systems are to separate the nomal patient, with all nomal system enreres, p who needs additional studies of any of these parameters. These studies measurem imatano somrical of the antyrer and a suice of anneliza marker ormulario m national beranters mored the securitment milled del dinam minutare de propriamente del minder desi Parameters: WBC, Lymph #, Mo #, Gran#, Lymph %, Mo%, Gran%, RBC, HGB, HCT%, MCV, MCH, MCHC, RDW, RDW- SD, PLT, MPV. two counting modes, whole blood and prediute mode. The two modes is the amount of sample of sample ar

AI/ML Overview

The provided text is a 510(k) submission for the DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis Systems. It describes the device, its intended use, predicate devices, and summaries of performance studies.

Here's an analysis of the acceptance criteria and the studies that demonstrate the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list quantitative "acceptance criteria" with specific thresholds for each performance metric. Instead, it states that the studies "demonstrated comparable results" or "acceptable results" or "met the internal validation acceptance criteria" when compared to predicate devices or established guidelines.

Here's a table summarizing the studies and their reported outcomes, as this is the closest we can get to the requested information from the provided text:

Study	Acceptance Criteria (Inferred from study design and predicate comparison)	Reported Device Performance (DxH™ 300/300C)
Accuracy	Comparable results to the predicate device (COULTER® AcT Diff 2 ™) for all parameters (WBC, Lymph #, Mo #, Gran#, Lymph %, Mo%, Gran%, RBC, HGB, HCT%, MCV, MCH, MCHC, RDW, PLT, MPV) and COULTER® LH 780 for RDW-SD.	"The DxH 300 systems demonstrated comparable results to the predicate device with reagents stated above."
Precision	Acceptable precision performance as per CLSI EP5-A2.	"The DxH 300 systems demonstrated acceptable results with reagents stated above."
Linearity	Acceptable linearity results as per CLSI EP06-A.	"The DxH 300 systems demonstrated acceptable linearity results."
Carryover	Acceptable carryover results as per ICSH guidelines.	"The DxH 300 systems demonstrated acceptable carryover results."
Specimens (Stability)	Acceptable sample and prepared sample stability.	"Acceptable sample and prepared sample stability results achieved."
Reference Values	Reference intervals established as per CLSI C28-A3.	"Reference intervals established."
Performance (Normal & Clinical Samples)	Met internal validation acceptance criteria for analysis of normal and clinical samples as per CLSI H20-A2.	"The DxH 300 systems analysis of normal and clinical samples met the internal validation acceptance criteria"

Note: The specific quantitative acceptance thresholds for "comparable" or "acceptable" are not detailed in this summary document. These would typically be found in the full study reports.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for the test set in any of the studies (Accuracy, Precision, Linearity, Carryover, Specimen Stability, Reference Values, Performance).

The data provenance (e.g., country of origin, retrospective/prospective) is also not stated in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the involvement of experts or how many were used to establish ground truth for any of the studies. These are automated hematology analyzers, and ground truth for many of these parameters is typically established through reference methods, calibrated standards, or comparative analysis with established predicate devices, rather than expert consensus on individual results. However, the accuracy study mentions CLSI H20-A2, which is for Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods. This standard sometimes involves manual differential counts performed by trained laboratorians, but this document does not explicitly confirm this for the ground truth collection for this device.

4. Adjudication Method

The document does not describe any adjudication method like 2+1 or 3+1. Given the nature of an automated cellular analysis system, adjudication processes like these, which are common in image-based diagnostic AI, are typically not relevant. The studies focus on consistency, accuracy against reference methods, and comparison to predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, the document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is an automated hematology analyzer, meaning it performs the analysis without direct human interpretation of individual images/data points in the same way a radiologist interprets an X-ray. It's designed to provide quantitative results directly, with flags for abnormalities. Therefore, a study to measure human reader improvement with AI assistance would not be applicable in this context.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies for the algorithm. The descriptions of "Accuracy," "Precision," "Linearity," "Carryover," "Specimens," "Reference Values," and general "Performance" all refer to the direct performance of the DxH 300/300C system itself, without human intervention in the primary measurement and calculation of the indicated parameters (WBC, RBC, HGB, etc.). The goal is to show the device performs acceptably on its own.

7. Type of Ground Truth Used

The type of ground truth used can be inferred from the reference standards cited:

Accuracy: Ground truth was established by comparison to the predicate devices (COULTER® AcT Diff 2 ™ and COULTER® LH 780), which implies that the predicate devices served as a de facto "gold standard" or established reference method. The CLSI H20-A2 standard, referenced for WBC differential count, suggests that for differential parameters, ground truth might involve manual microscopy, although this isn't explicitly stated as the method within this document.
Precision, Linearity, Carryover: Ground truth for these studies relies on statistically controlled experiments using characterized samples or materials, or comparison to established industrial standards (CLSI guidelines, ICSH document). For linearity, a range of samples with known values would be used.
Reference Values: Established using healthy populations, based on CLSI C28-A3.
Performance (Normal & Clinical Samples): Ground truth for evaluating normal and clinical samples would be based on clinical diagnoses and reference methods for the parameters being measured (likely including results from predicate devices or other established analyzers).

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. As this device is a physical instrument rather than a machine learning algorithm in the modern sense (though it undoubtedly contains complex algorithms), the concept of a "training set" might not apply in the same way it does for a deep learning model. Device calibration and parameter optimization would have occurred during development, but specifics are not in this summary.

9. How the Ground Truth for the Training Set Was Established

Similarly, as a "training set" for a distinct AI algorithm is not explicitly mentioned, the document does not describe how ground truth for any training set was established. The development and calibration of such instruments typically involve extensive internal testing, using reference materials, characterized patient samples, and comparison to existing validated technologies. This process establishes the expected output and performance characteristics against which the device is optimized.

Summary

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510(k) Summary
OxH™ 300 COULTER® Cellular Analysis Syst
xH™ 300C COULTER® Cellular Analysis Syst

1 < 1 0 6 4 89

OCT 2 6 2010

ubmitted By 1 .0

eanne Roscole
Stocker Bundlery Inne.
Stoken Studitory Inne.
Prokoman Billy Markery Inno.
Marka BW City And Android Andres MCC: 31-B06
Milami, IPIonis 23, 1996-23800
PAX: (78

Date Submitted 2.0

ebruary 18, 2010

3.0

Dexise Name=Classification
DxHTM 300 COULTER® Cellular Analysis System
DxHTM 300 COULTER® Cellular Analysis System
Automated differential cellular Analysis System
(21 CFR $

edicate Devices 4.0

Candidate	Predicate	Manufacturer	Docket Number
DxH™ 300 and DxH™ 300C	COULTER® AcT Diff 2™	Beckman	K990352
COULTER® Cellular Analysis System	COULTER® LH 780Hematology Analyzer	Coulter, Inc.	K061616

Beckman Coulter, Inc.
DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis 3
510(k) Submission

{1}------------------------------------------------

escription 5.0

1 300 and DxH™ 300C COUL TER® Cellular Analysis Analyzes are intended for In Vitro Diagnostic
clinical laboratories. The DxH 300C has the capability to process samples in an fferentials

pos of the DxH 300 Systems are to separate the nomal patient, with all nomal system enreres, p
who needs additional studies of any of these parameters. These studies measurem

imatano somrical of the antyrer and a suice of anneliza marker ormulario
m national beranters mored the securitment milled del dinam minutare de propriamente del minder desi

Parameters: WBC, Lymph #, Mo #, Gran#, Lymph %, Mo%, Gran%, RBC, HGB, HCT%, MCV, MCH, MCHC, RDW, RDW-
SD, PLT, MPV.

two counting modes, whole blood and prediute mode. The two modes is the amount of sample of sample ar

ntended Use 6.0

ﺍ 140 COULTER Collub And Collins Mallion Submit Collular Mallyan Democracy Premace anamaria
20 Symmand ABA Collula Calino Santo Marca Marcher Del Collect Collection Collecti

Beckman Coulter, Inc.
OxH™ 300 and DxH™ 300C COULTER® Cellular Anal
510(k) Submission

age 2 of .

{2}------------------------------------------------

And A. Box Bear Bron

œ1	A CHRAN CHALLER CHE
1

Attribute	COULTER® AcT Diff 2 ™Predicate for all Parameters except RDW-SDand extended Platelet/WBC Linearity	COULTER® LH 780Predicate for RDW-SD, Platelet and WBC extendedLinearity	DxH™ 300/300C COULTER® CellularAnalysis System
Intended Use	The COULTER ACT Diff 2 analyzeris a quantitative, automatedhematology analyzer and leukocytedifferential counter For In VitroDiagnostic Use in clinicallaboratories. The purpose is toidentify the normal human patient,with all normal system-generatedparameters, and to flag or identifypatient results that require additionalstudies.	The COULTER LH 780 Hematology Analyzer isa quantitative, automated hematology analyzerand leukocyte differential counter For In VitroDiagnostic Use in clinical laboratories. TheCOULTER LH 780 Hematology Analyzerprovides automated Reticulocyte analysis andenumeration of nucleated red blood cells(NRBCs) as well as an automated method forenumeration of RBCs and WBCs in body fluids.	The DxH 300 COULTER Cellular AnalysisSystem and the DxH 300C COULTER CellularAnalysis System are quantitative automatedhematology analyzers for in vitro diagnostic usein clinical laboratories. The DxH 300COULTER Cellular Analysis System and theDxH 300C COULTER Cellular AnalysisSystem provide complete blood count, (WBC,RBC, HGB, HCT, MCV, MCH, MCHC, RDW,RDW-SD, PLT, MPV) and Leukocyte 3-PartDifferential [LY (%/#), MO (%/#), GR (%/#)]for whole blood specimens, collected in a salt ofEDTA [dipotassium (K2) or tripotassium (K3)]obtained by venipuncture, heel or fingerstick.The purpose of the DxH 300 and the DxH 300Cis to identify normal human patients, withnormal system-generated parameters, frompatients whose results require additional studies.
DeviceClassificationand ProductCode	864.5220, Automated Cell Counter,GKZ	Same	Same
Parameters	WBC, RBC, Hgb, Hct, MCV, MCH,MCHC, RDW, Plt, MPV, LY%,MO%, GR%, LY#, MO#and GR#	WBC, RBC, Hgb, Hct, MCV, MCH, MCHC,RDW, RDW-SD, Plt, MPV, LY%, MO%, NE%,EO%, BA%, LY#, MO#, NE#, EO#, BA#,RBC%, NRBC#, RET%, RET#, IRF and MRV.	Same as AcT Diff 2 with the addition of RDW-SD
Quality ControlTechniques	Daily Instruments Check,Commercial Controls, PatientControls, Inter-laboratory QualityAssurance Program (IQAP)	Same as ACT Diff 2 PLUS Delta Checks, XBAnalysis, Extended QC and XM Analysis	Same as AcT Diff 2 with addition of XBAnalysis, Extended QC and XM Analysis

Beckman Coulter, Inc.
DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis System
S10(k) Submission

{3}------------------------------------------------

Attribute	COULTER® AcT Diff 2 ™Predicate for all Parameters except RDW-SD and extended Platelet/WBC Linearity	COULTER® LH 780Predicate for RDW-SD, Platelet and WBC extended Linearity	DxH™ 300/300C COULTER® Cellular Analysis System
AnalysisReagents	COULTER® ISOTON® III DiluentCOULTER® LYSE S® III Diff Lytic Agent	COULTER® LH Series DiluentCOULTER® Isoton 4 DiluentCOULTER® LH Series PakCOULTER® LH Series Retic PakCOULTER® Lyse S® III Lytic AgentCOULTER® Lyse S® 4 Lytic Agent	DxH™ 300 Pack-contains COULTER® DxH Diluent (Optimized Isoton 4 Diluent) and COULTER® DxH Cell Lyse (Same as Lyse S® 4 lytic agent)DxH 300 Rinse
Quality Control& Calibrators	COULTER® 4C® Plus Cell ControlCOULTER® 4C-ES Cell ControlCOULTER® S-CAL® Calibrator KitCOULTER® LIN-C® Linearity Control	COULTER® 5C® Cell ControlCOULTER® Latron™ Primer and Latron ControlCOULTER® LIN-C® Linearity ControlCOULTER® S-CAL® Calibrator KitCOULTER® Retic-C™ Cell Control	COULTER® 4C-EX 300 Cell ControlCOULTER® LIN-X Linearity ControlCOULTER® S-CAL® Calibrator Kit
CleaningAgents	COULTER® AcT Rinse ShutdownDiluent	COULTER® LH Series Cleaner	COULTER® DxH CleanerSame as AcT Diff 2 except DxH 300 does not perform closed vial sampling
SampleIntroduction	Manual presentation for open or closed vial sampling whole blood analysis and pre-dilute mode	Manual presentation for open vialAutomated presentation for closed vial sampling from 12 position cassette. Maximum load capacity 12 racks

8.0

Study	Study Design	Study Results
Accuracy	Based on CLSI EP9-A2, Method Comparison and BiasEstimation Using Patient Samples; Approved Guideline –Second Edition. Testing was done in accordance with CLSIH20-A2 Reference Leukocyte (WBC) Differential Count(Proportional) and Evaluation of Instrumental Methods;Approved Standard – Second Edition	The DxH 300 systems demonstrated comparable resultsto the predicate device with reagents stated above.
Study	Study Design	Study Results
Precision	Based on CLSI EP5-A2, Evaluation of PrecisionPerformance of Quantitative Measurement Methods;Approved Guideline – Second Edition.	The DxH 300 systems demonstrated acceptable resultswith reagents stated above.
Linearity	Based on CLSI EP06-A, Evaluation of the Linearity ofQuantitative Measurement Procedures: A StatisticalApproach; Approved Guideline	The DxH 300 systems demonstrated acceptable linearityresults.
Carryover	Reference to the ICSH document: Guidelines for theEvaluation of Blood Cell Analyzers including those used fordifferential leukocyte and reticulocyte counting and cellmarker applications. International Council forStandardization in Haematology: prepared by the ICSHexpert panel on cytometry. Clin Lab Haematol, 16(2):157-174, 1994	The DxH 300 systems demonstrated acceptablecarryover results.
Specimens	Specimen collection was done in accordance with CLSI H3-A6- Procedures for the Collection of Diagnostic BloodSpecimens by Venipuncture: Approved Standard- SixthEdition	Acceptable sample and prepared sample stability resultsachieved.
Reference Values	Based on CLSI C28-A3, Defining, Establishing, andVerifying Reference Intervals in the Clinical Laboratory,Approved Guideline – Third Edition	Reference intervals established.
Performance	Testing was done in accordance with CLSI H20-A2Reference Leukocyte (WBC) Differential Count(Proportional) and Evaluation of Instrumental Methods;Approved Standard – Second Edition	The DxH 300 systems analysis of normal and clinicalsamples met the internal validation acceptancecriteria

Beckman Coulter, Inc.
DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis System
510(k) Submission

Page 4 of 5

10(k) submissions

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The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already
sommercial distribution.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act
1990 and the implementing regulation 21 CFR 80

Beckman Coulter, Inc.
DxHT* 300 and DxHT* 300C COULTER® Cellular Analysis System
510(k) Submission

Page 5 of 5

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle, with three stylized lines representing the bird's wings and body. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center -- WO66-0609 Silver Spring, MD 20993-0002

Beckman Coulter, Inc. c/o Ms. Jeanne Roscoe Senior Regulatory Specialist 11800 S.W. 147th Avenue MS 31 B06 Miami, FL 33196-2500

OCT 2 6 2010

Re: K100489

Trade/Device Name: DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis Systems Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: September 29, 2010 Received: September 30, 2010

Dear Ms. Roscoe:

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 (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. 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.

If your device is classified (see above) into class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter

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Page 2 - Ms. Jeanne Roscoe

will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Maria M Cham

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

K100489

OCT 2 6 2010

510(k) Number (K100489):

Device Name: DxH™ 300 COULTER® Cellular Analysis Analyzer DxH™ 300C COULTER® Cellular Analysis Analyzer

Indication For Use:

The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System are quantitative automated hematology analyzers for in virro diagnostic use in clinical laboratories. The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System provide complete blood count, (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV) and Leukocyte 3-Part Differential [LY (%/#), MO (%/#), GR (%/#)] for whole blood specimens, collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained by venipuncture, heel or fingerstick. The purpose of the DxH 300 and the DxH 300C is to identify normal human patients, with normal system-generated parameters, from patients whose results require additional studies.

Prescription Use __ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K100489

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.”