The COULTER® A•T™ 5diff Cap Pierce (CP) hematology analyzer is a 26-parameter, fully automated hematology analyzer including a five-part leukocyte differential counter capable of analyzing samples in a closed vial or open vial mode.

Device Description

The COULTER® A • T™ 5diff Cap Pierce (CP) is a moderate cost 5-part differential hematology analyzer that consists of the analyzer, a personal computer (PC) workstation and a printer.

AI/ML Overview

Acceptance Criteria and Device Performance Study for COULTER® A•T™ 5diff Cap Pierce (CP)

This document describes the acceptance criteria and a detailed study supporting the performance of the COULTER® A•T™ 5diff Cap Pierce (CP) hematology analyzer.

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of predetermined acceptance criteria with corresponding performance results in a consolidated format. However, based on the context of a 510(k) submission for an automated differential cell counter, the primary acceptance involves demonstrating substantial equivalence to predicate devices. This implies meeting or performing comparably to the established performance of the legally marketed predicate devices, specifically the COULTER® HmX with Autoloader (K922704/A1) and the COULTER® A•T™ 5diff Autoloader (AL) (K030291, K032013).

The summary of the performance data states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence studies of the COULTER® A^T™ 5diff Cap Pierce (CP) Hematology Analyzer to products already in commercial distribution."

While specific numerical acceptance criteria (e.g., precision, accuracy, linearity targets) and detailed performance metrics are not provided in this summary, the FDA's clearance (K042173) confirms that the submitted data met the regulatory requirements for demonstrating substantial equivalence. The comparison table of features (parameters measured, principles of measurement, sample volume, throughput) between the candidate device and the predicates indicates that the COULTER® A•T™ 5diff Cap Pierce (CP) offers largely the same core functionality and technology as its predicates. The key new feature for the COULTER® A•T™ 5diff CP is the "Cap Pierce" capability, allowing closed-vial sampling, which would have been a primary area for demonstrating equivalent performance to ensure it doesn't negatively impact the analytical results.

Inferences on Acceptance Criteria (Typical for such devices):

Based on typical FDA requirements for automated differential cell counters, acceptance criteria would generally revolve around:

Accuracy/Correlation: High correlation coefficients (e.g., r > 0.95 or 0.98) and minimal bias when comparing results obtained from the new device against the predicate devices or reference methods (e.g., manual differential counts adjudicated by experts) for all reported parameters (WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, Plt, MPV, Pct, Lymphocyte %, Monocyte %, Neutrophil %, Eosinophil %, Basophil %).
Precision (Reproducibility & Repeatability): Low coefficients of variation (CV%) for all measured parameters, indicating consistent results over multiple measurements.
Linearity/Reportable Range: Demonstrating accurate measurements across the clinically relevant analytical range for each parameter.
Carryover: Minimal transfer of sample material from one run to the next.
Interference Studies: Performance unaffected by common interfering substances.
Reference Intervals: Establishing appropriate normal ranges.
Warning/Flagging Performance: Correct identification and flagging of abnormal or immature cells.

Reported Device Performance:
The document explicitly states that the "data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence." This means the device's performance, as detailed in the full submission, met the necessary thresholds to demonstrate it is as safe and effective as the predicate devices. Without access to the full Premarket Notification, specific numerical performance results cannot be reported here.

2. Sample Size and Data Provenance for the Test Set

The provided summary does not specify the sample size used for the test set in the substantial equivalence studies. It also does not explicitly mention the data provenance (e.g., country of origin, retrospective or prospective).

For a 510(k) submission, clinical validity and analytical validity studies are typically conducted. These studies would involve analyzing a sufficient number of patient samples (e.g., hundreds to thousands, including normal and abnormal samples) to demonstrate statistical equivalence. The samples are generally collected prospectively in a clinical laboratory setting to reflect real-world conditions.

3. Number and Qualifications of Experts for Ground Truth

The summary does not specify the number of experts or their qualifications used to establish ground truth for the test set.

For automated differential cell counters, ground truth for leukocyte differential counts and abnormal cell flagging is typically established by:

Manual microscopy examination: Performed by highly experienced, board-certified clinical laboratory scientists (medical technologists/technicians) specializing in hematology.
Pathologist review: In cases of disagreement or complex morphology, a board-certified hematopathologist (e.g., with 10+ years of experience) would adjudicate.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set.

Common adjudication methods for establishing ground truth in hematology include:

Consensus of 2 out of 3 experts: If three experts independently classify a cell or smear, the majority opinion forms the ground truth.
One senior expert review: A single highly experienced expert's opinion may serve as ground truth.
Two-plus-one (2+1): Two initial readers, and if they disagree, a third senior reader resolves the discrepancy.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess the improvement of human readers with vs. without AI assistance. The COULTER® A•T™ 5diff Cap Pierce (CP) is an automated analyzer, not a system primarily designed to provide AI assistance to human readers for interpretation, but rather to perform the differential count itself. Its purpose is to screen samples, flagging those that may require further manual review. Therefore, this type of MRMC study would be less relevant for this device.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was clearly performed. The entire premise of the 510(k) submission for the COULTER® A•T™ 5diff Cap Pierce (CP) is to demonstrate the performance of the algorithm and instrument as a standalone system. The device is an "Automated Differential Cell Counter," meaning its primary function is to perform the blood cell counts and differentials without human intervention for each count, then present the results. The "Summary of Performance Data" refers to studies of the device itself.

7. Type of Ground Truth Used

The type of ground truth used would typically be a combination of:

Reference instrument comparison: Comparing results against a legally marketed predicate device (e.g., COULTER® HmX or A•T™ 5diff AL) known for its established performance. This is the primary method for demonstrating "substantial equivalence."
Expert Consensus (Manual Microscopy): For parameters like leukocyte differential and abnormal cell identification, manual microscopy performed by qualified laboratory personnel, often adjudicated by expert consensus, would be used as the gold standard.
Reference Methods: For certain parameters (e.g., hemoglobin), calibrated reference methods might be used.

The document implicitly relies on the established performance of its predicate devices, indicating that the ground truth for validating its substantial equivalence would likely involve a direct comparison to these predicate instruments and standard laboratory reference methods.

8. Sample Size for the Training Set

The provided summary does not specify the sample size for the training set. If this device utilized a machine learning algorithm for its differential classification (which is common for modern differential counters), a large number of diverse samples would be required for training the algorithm.

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

The document does not specify how the ground truth for the training set was established.

For a hematology analyzer employing a differential algorithm, the ground truth for training data would typically be established similarly to the test set:

Manual Microscopy with Expert Review: Each cell in the training samples would be identified and classified by highly experienced medical technologists or hematopathologists using manual microscopy, often with a consensus process (e.g., 2 out of 3 experts agreeing) to ensure accuracy.
Correlation with Reference Methods: For quantitative parameters, the results would be correlated with established reference methods.
Large, Diverse Dataset: The training set would need to include a wide range of normal and abnormal blood samples, covering various pathologies, cell types, and demographic variations, to ensure the algorithm learns to accurately classify different cellular morphologies.

Summary

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0007 1 2 2004

K042173

Summary of Safety & Effectiveness COULTER® A • T™ 5diff Cap Pierce (CP)

1.0 Submitted By:

Lourdes Coba Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4079 FAX: (305) 380-3618

2.0 Date Submitted:

August 10, 2004

3.0 Device Name:

3.1 Proprietary Name

COULTER® Aº T™ 5diff Cap Pierce (CP)

3.2 Classification Name

Automated Differential Cell Counter (21 CFR § 864.5220)

The special control for this submission is the FDA document "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counter for Immature or Abnormal Blood Cells: Final Guidance for Industry and FDA".

4.0 Predicate Device(s):

Candidate	Predicate #1	Manufacturer	DocketNumber
COULTER® Ac•TTM5diff Cap Pierce (CP)	COULTER® HmXwith Autoloader	Beckman Coulter, Inc.	K922704/A1
	Predicate #2COULTER® Ac•TTM5diff Autoloader (AL)	Beckman Coulter, Inc.	K030291 K032013

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5.0 Description:

The COULTER® A • T™ 5diff Cap Pierce (CP) is a moderate cost 5-part differential hematology analyzer that consists of the analyzer, a personal computer (PC) workstation and a printer.

6.0 Intended Use:

The COULTER® A . TM 5diff Cap Pierce (CP) hematology analyzer is a 26parameter, fully automated hematology analyzer including a five-part leukocyte differential counter capable of analyzing samples in a closed vial or open vial mode.

Clinical Significance:

The purpose of the A · TM 5diff CP is to separate the normal patient, with all normal system-qenerated parameters from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size, and/or distribution, manual WBC differential or any other derivative test that helps diagnosis of the patient's condition.

Comparison to Predicate(s): 7.0

The COULTER® A ° T™ 5diff Cap Pierce (CP) is substantially equivalent to the COULTER® HmX with Autoloader and the COULTER® A -T™ 5diff Autoloader (AL) from Beckman Coulter, Inc.

	Predicate Device (1)Beckman CoulterHmX with AL	Predicate Device (2)Beckman CoulterA•T 5diff AL	DeviceBeckman CoulterA•T 5diff CP
Parameters	24WBC, RBC, Hgb, Hct, MCV,MCH, MCHC, RDW, Plt,MPV, PDW, Pct, Lymphocyte % & #,Monocyte % & #Neutrophil % & #Eosinophil % & #Basophil % & #Reticulocyte % & #* These parameters are forResearch Use Only (RUO).Not for use in diagnosticprocedures	26WBC, RBC, Hgb, Hct,MCV, MCH, MCHC,RDW, Plt, MPV, PDW, Pct, Lymphocyte % & #,Monocyte % & #Neutrophil % & #Eosinophil % & #Basophil % & #Atypical Lymph % & # Immature cell % & # N/A* These parameters arefor Research Use Only(RUO). Not for use indiagnostic procedures	26WBC, RBC, Hgb, Hct,MCV, MCH, MCHC,RDW, Plt, MPV, PDW, Pct, Lymphocyte % & #,Monocyte % & #Neutrophil % & #Eosinophil % & #Basophil % & #Atypical Lymph % & # Immature cell % & # N/A* These parameters arefor Research Use Only(RUO). Not for use indiagnostic procedures

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Principles ofMeasurement
WBC	Aperture Impedance	Aperture Impedance	Aperture Impedance
RBC	Aperture Impedance	Aperture Impedance	Aperture Impedance
Hgb	Spectrophotometric	Spectrophotometric	Spectrophotometric
MCV	Aperture Impedance	Calculated from Hct	Calculated from Hct
Hct	Calculated from MCV	Aperture Impedance	Aperture Impedance
Plt	Aperture Impedance	Aperture Impedance	Aperture Impedance
Differential	Aperture ImpedanceConductivity, Laser LightScatter (VCS)	Aperture ImpedanceLight Scattering	Aperture ImpedanceLight Scattering
Retics	Laser Light Scatter	N/A	N/A
SampleVolume	Closed Vial Mode - 185μLOpen Vial Mode- 125μL	Open and Closed VialModesCBC profile - 30μLCBC/DIFF profile - 53μL	Open and Closed VialModesCBC profile - 30μLCBC/DIFF profile - 53μL
Throughput	Closed and Open VialModes - 75 samples/hourRetics - 30 samples/hour	Closed and Open VialModes -Up to 80 samples/hour	Closed and Open VialModes -Up to 60 samples/hour

Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence studies of the COULTER® A^T™ 5diff Cap Pierce (CP) Hematology Analyzer to products already in commercial distribution.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Lourdes Coba Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147th Avenue MC: 31-B06 Miami, Florida 33196-2500

OCT 1 2 2004

K042173 Re:

Ro 12773
Trade/Device Name: COULTER® Af*T™ 5diff Cap Pierce (CP) Hematology Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: August 10, 2004 Received: August 11, 2004

Dear Mr. Coba:

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 I va mayy are sever sions 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 either class II (Special Controls) or class III (PMA), 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 or any I 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); and good manufacturing practice OFF Part 6017, laborning (QS) regulation (QS) regulation (21 CFR Part 820). This letter requirences as be rent arketing your device as described in your Section 510(k) premarket while and of your to organizatial 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.

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Page 2

If you desire specific information about the application of labeling requirements to your device, of In II you desire specific information acceded the of your device, please contact the Office of In or questions on the promotion and Safety at (301) 594-3084. Also, please note the VIIIO Diagnostic Device Device and the mail and the motification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket and a des Art from the You may obtain other general information on your responsibilities under the Act from the You may outan other general mormational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., 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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of page

510(k) Number (if known): KOYJ / 73

COULTER® Aº•T™ 5diff Cap Pierce (CP) Hematology Device Name: Analyzer

Indications for Use:

The COULTER® A°•T™ 5diff Cap Pierce (CP) hematology analyzer is a 26-The COUL fLK® A v -----------------------------------------------------------------------------------------------------------------------------------------------------------parameter, fully adtomation nomalyzing samples in a closed vial or open vial mode.

864.5240 Automated Differential Cell Counter

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 one of the or the formou classify immature or abnormal hematopoietic cells of capability to liag, ooun, or other body fluids. These devices may combine an the blood, bone marrow, or eathor, optical method, or a flow cytometric method electionic partiolo obanting mothers, spiration) markers. The device includes accessory CD markers.

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
Optional Format 1-2-96

Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K042173

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.”