The COULTER® AcT™ 5diff Autoloader (AL) hematology analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories.

The COULTER® AcT™ 5diff Autoloader (AL) hematology analyzer is a 26parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).

Device Description

The COULTER® AcT™ 5diff Autoloader (AL) is a moderate cost 5-part differential hematology analyzer with autoloader and external computer workstation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the COULTER® AcT™ 5diff Autoloader (AL), based on the provided document. Please note that the document is a 510(k) summary, which often provides an overview rather than detailed study results. Consequently, some specific details like exact confidence intervals, full statistical analyses, or the exact improvement effect size in an MRMC study if conducted for this type of device, are not explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table with specific pass/fail thresholds. Instead, it relies on substantial equivalence to predicate devices (Beckman Coulter HmX with Autoloader and Abbott CELL-DYN 4000) for its performance. The "reported device performance" is primarily characterized by the parameters measured and the principles of measurement, which are fundamentally similar to the predicates. The clinical significance also outlines the intended performance: to accurately identify normal patients from those needing further studies.

Here's an attempt to structure what can be inferred as performance benchmarks based on the comparison to predicate devices:

Characteristic/Parameter	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (COULTER® AcT™ 5diff AL)
Parameters Measured	Similar range and type of hematology parameters, including 5-part differential, as predicate devices.	26 parameters: WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, Plt, MPV, PDW, Pct, Lymphocyte % & #, Monocyte % & #, Neutrophil % & #, Eosinophil % & #, Basophil % & #, Atypical Lymphocyte % & # , Immature cell % & #
Principles of Measurement	Similar measurement technologies for core parameters (WBC, RBC, Hgb, Plt, Differential).	WBC, RBC, Plt: Aperture impedance. Hgb: Spectrophotometric. MCV: Calculated from Hct. Hct: Aperture impedance. Differential: Aperture Impedance, Light Scattering.
Sample Volume	Comparable to predicate devices.	CBC profile - 30 µL; CBC/DIFF profile - 53 µL (significantly lower than predicates)
Throughput	Comparable to predicate devices.	Closed and Open vial mode - 80 samples/hour (comparable to higher end of predicates)
Intended Use	Quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use, distinguishing normal from abnormal for further study.	Identical.

*These parameters are for Research Use Only (RUO). Not for use in diagnostic procedures.

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

The document is a 510(k) summary, which typically focuses on product characteristics and substantial equivalence, and does not provide details on the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It simply states that "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence studies..." without elaborating on the studies themselves.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The 510(k) summary does not describe how ground truth was established for any performance studies.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This document does not indicate that an MRMC comparative effectiveness study was done. This type of study (human readers with vs. without AI assistance) is more common for diagnostic imaging AI devices, rather than automated lab analyzers like the COULTER® AcT™ 5diff Autoloader (AL), which are typically evaluated for accuracy, precision, and agreement with established methods rather than human performance improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the device itself, an automated hematology analyzer, inherently operates in a "standalone" fashion as an algorithm-only device (though used in a clinical lab setting with human oversight for interpretation and follow-up). The summary implies that its performance was assessed independently to demonstrate substantial equivalence to existing automated analyzers. The performance data supports a finding of substantial equivalence, meaning its accuracy and reliability were assessed on its own merits against established predicate devices.

7. Type of Ground Truth Used

The specific type of ground truth used is not explicitly stated. For hematology analyzers, ground truth is typically established by:

Reference methods: Such as manual differential counts performed by highly experienced medical technologists, or other established automated analyzers.
Clinical outcomes/diagnoses: Though less direct for individual parameter accuracy.
Split samples: Running samples on both the new device and a predicate/reference device and comparing results.

Given the context of substantial equivalence to predicate devices, it is highly probable that the ground truth was established by comparison to results obtained from the predicate devices or other established reference methods.

8. Sample Size for the Training Set

This information is not provided in the document. The document does not discuss the training of any AI or machine learning models, as the device is an automated hematology analyzer using impedance and light scattering principles, rather than a deep learning AI device. If it were a predictive model, such information would be crucial.

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

This information is not applicable and not provided. As mentioned above, the document does not suggest the use of a "training set" in the context of machine learning. The device operates based on established physical principles of cell measurement.

Summary

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K03029/

Summary of Safety & Effectiveness COULTER® AcT™ 5diff Autoloader (AL)

1.0 Submitted By:

APR 1 7 2003

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:

January 27, 2003

3.0 Device Name(s):

3.1 Proprietary Names

COULTER® AcT™ 5diff Autoloader (AL)

3.2 Classification Name

Automated Differential Cell Counter (21 CFR § 864.5220)

4.0 Predicate Device:

Candidate(s)	Predicate #1	Manufacturer	Docket Number
COULTER® AcT TM 5diffAutoloader (AL)	COULTER® HmX withAutoloader	Beckman Coulter, Inc.	K922704/A1
	CELL-DYN® 4000*	Abbott Diagnostics**	K961439

Trademark of Abbott Diagnostics

** Abbott Diagnostics, 5440 Patrick Henry Drive, Santa Clara, CA.

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5.0 Description:

The COULTER® AcT™ 5diff Autoloader (AL) is a moderate cost 5-part differential hematology analyzer with autoloader and external computer workstation.

6.0 Intended Use:

Clinical Significance:

The purpose of the AcT 5diff AL is to separate the normal patient, with all normal system-generated 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, biochemical investigations, manual WBC differential or any other derivative test that helps diagnosis of the patient's condition.

7.0 Comparison to Predicate(s):

COULTER® AcT™ 5diff Autoloader (AL) is substantially equivalent to theBeckman Coulter HmX with Autoloader and the Abbott CELL-DYN 4000.

	Predicate Device (1)	Predicate Device (2)	Device
	Beckman CoulterHmX with Autoloader	AbbottCELL-DYN CD4000	Beckman CoulterA°•T 5diff AL

Parameters	24	28	26
	WBC, RBC, Hgb, Hct,	WBC, RBC, Hgb, Hct,	WBC, RBC, Hgb, Hct,
	MCV, MCH, MCHC,	MCV, MCH, MCHC,	MCV, MCH, MCHC,
	RDW, Plt, MPV, PDW*,	RDW, Plt, MPV, PDW*,	RDW, Plt, MPV, PDW*,
	Pct*,	Pct*, WBC Viable	Pct*,
	Lymphocyte % & #,	Fraction*, NRBC #,	Lymphocyte % & #,
	Monocyte % & #	NRBC / 100 WBC	Monocyte % & #
	Neutrophil % & #	Lymphocyte % & #,	Neutrophil % & #
	Eosinophil % & #	Monocyte % & #	Eosinophil % & #
	Basophil % & #	Neutrophil % & #	Basophil % & #
		Eosinophil % & #	Atypical Lymph % & # *
		Basophil % & #	Immature cell % & # *
	Reticulocyte % & #	Reticulocyte % & #IRF	N/A
	* These parameters are	* These parameters are	• These parameters are
	for Research Use Only	for Research Use Only	for Research Use Only
	(RUO). Not for use in	(RUO). Not for use in	(RUO). Not for use in
	diagnostic procedures	diagnostic procedures	diagnostic procedures

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Principles ofMeasurement
WBC	Aperture impedance	Aperture Impedance /Laser Light Scatter-	Aperture impedance
RBC	Aperture impedance	Aperture Impedance /Laser Light Scatter	Aperture impedance
Hgb	Spectrophotometric	Spectrophotometric	Spectrophotometric
MCV	Aperture impedance	Aperture Impedance /Laser Light Scatter	Calculated from Hct
Hct	Calculated from MCV	Calculated from MCV	Aperture impedance
Plt	Aperture impedance	Aperture Impedance /Laser Light Scatter	Aperture impedance
Differential	Aperture impedanceConductivity, Laser LightScatter (VCS)	Multi- angle PolarizedScatter Separation(MPASS)	Aperture ImpedanceLight Scattering
Retics	Laser Light Scatter	Laser Light Scatter	N/A
NRBC andNon viablecells	N/A	Laser Light Scatter	N/A
SampleVolume	Closed Vial Mode - 185µLOpen Vial Mode- 125µL	Manual or AutomaticModes - 115µL	Open and Closed vialmodesCBC profile - 30 µLCBC/DIFF profile - 53µL
Throughput	Closed and Open Vialmode - 75 samples/hourRetics - 30 samples/hour	Closed tube mode -115 samples/hourOpen Tube mode -72 samples/hour	Closed and Open vialmode -80 samples/hour

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence studies of the COULTER® AcT 5diff AL 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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Administrative Information COULTER® AcT™ 5diff Autoloader (AL)

1.0 SUBMITTED BY:

Beckman Coulter, Inc. 11800 SW 147th Avenue MC: 31-B06 Miami, FL 33196-2500 Establishment Registration No. 1061932

Primary Contact: Lourdes Coba, Senior Regulatory Affairs Specialist Telephone: (305) 380-4079 FAX: (305) 380-3618

Secondary Contact: Deborah Herrera, Group Manager, Regulatory Affairs Telephone: (305) 380-4013 FAX: (305) 380-3618

2.0 PRODUCT NAME:

A. PROPRIETARY NAME: COULTER® AcT™ 5diff Autoloader (AL)
B. CLASSIFICATION NAME: Automated Differential Cell Counter (21 CFR § 864.5220)

3.0 CLASSIFICATION:

FDA classifies this instrument as a Class II device.

4.0 COMPLIANCE WITH & 514:

Neither performance standards nor other special controls have been promulgated for this test system.

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Image /page/4/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 a stylized image of a human figure embracing a three-lined symbol, which represents the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 7 2003

Ms. Lourdes Coba Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 S.W. 147 Avenue M/S 31-Bo6 Miami, FL 33196-2500

Re: K030291

Trade/Device Name: COULTER® AcT™ 5diff Autoloader (AL) Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: January 27, 2003 Received: January 28, 2003

Dear Ms. 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 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 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 030291

COULTER® AcT™ 5diff Autoloader (AL) Hematology Analyzer Device Name:

Indications for Use:

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 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 cvtometric method utilizing monoclonal CD (cluster designation) 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

Spin Bauti

(Division Sign-Off)
Division of Clinical Laboratory Devices K030291
510(k) Number

Beckman Coulter. Inc., Abbreviated 510(k) Notification AcT 5diff AL Section1.doc

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.”