The COULTER® AcT™ 5diff AL Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.

Device Description

The Beckman Coulter, Inc. (BCI) Coulter® Ac•T™ 5diff Autoloader Hematology Analyzer (AcT™ 5diff AL) is a bench top laboratory instrument, designed for In Vitro diagnostic use in clinical laboratories. The AcT™ 5diff AL provides automated complete blood counts (CBC) and leukocyte differential counts. The instrument is microprocessor driven with a PC that performs data processing and data management activities.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the COULTER® AcT™ 5diff Autoloader (AL) Hematology Analyzer, based on the provided document.

Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's intended use and modifications. It does not explicitly list specific acceptance criteria (e.g., minimum accuracy percentages, precision targets) or detailed performance results in the format of a table. The "modification" section implies improvement characteristics without specifying them.

To adequately answer this, one would typically expect to see a section titled "Performance Testing" or "Clinical Performance" with quantitative data. The absence of such a section in this summary is notable.

However, based on what is implied by a 510(k) submission for a modified device, the "acceptance criteria" for a modified device like this would be that its performance characteristics are equivalent to or better than those of the predicate device, especially for the "improved performance characteristics" mentioned.

Therefore, the table below reflects what would typically be expected, but the specific numerical values for acceptance criteria and reported performance are NOT present in the provided text.

Performance Metric	Acceptance Criteria (Assumed from Equivalence)	Reported Device Performance (Not explicitly stated in document)
Accuracy	Performance equivalent to or better than predicate device (K030291 for AcT™ 5diff AL v1.00) for CBC and differential counts.	Not explicitly stated with specific numerical values (e.g., % agreement, correlation coefficient).
Precision	Performance equivalent to or better than predicate device (K030291 for AcT™ 5diff AL v1.00) for CBC and differential counts.	Not explicitly stated with specific numerical values (e.g., CV%).
Linearity (Platelet Count)	Performance equivalent to or better than predicate device (K022161 for COULTER® LH 750 Hematology Analyzer) for extended Platelet Count linearity.	Not explicitly stated with specific numerical values or range.
Interference	No significant interference affecting performance.	Not explicitly stated.
Carry-over	Acceptable carry-over rates.	Not explicitly stated.
Stability	Acceptable stability of results over time.	Not explicitly stated.
Functionality	All stated functionalities (automated CBC, differential counts, autoloader, Stat mode) perform as intended.	Implied by device description and 'improved performance characteristics'.

Study Details

Given the limited information in the provided document (which is a 510(k) summary, not a full study report), many of these details are not explicitly stated. This document primarily declares substantial equivalence and modifications.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified (country, retrospective/prospective).
- Note: Typical 510(k) submissions for such devices would involve testing with a range of patient samples (normal, abnormal) to assess performance across various clinical conditions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Note: For leukocyte differential counts, manual microscopy performed by experienced morphologists (e.g., clinical hematologists or highly trained medical technologists) is the gold standard.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
- Note: When multiple experts are used, a common adjudication method is to use consensus among a certain number of readers, with a tie-breaker (e.g., a third or fourth expert) if initial agreement is not reached.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this is highly unlikely. This device is an automated hematology analyzer, not an AI-assisted diagnostic tool that helps human readers interpret images or data. It generates the results that clinicians then interpret. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The device itself is an automated analyzer, meaning it operates in a standalone fashion to generate CBC and differential counts. Its performance would have been evaluated directly against a reference method (likely manual microscopy for differentials) without human intervention in the device's analytical process.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For CBC parameters (e.g., RBC, HGB, PLT): Likely established using reference methods on validated instruments or highly precise manual techniques.
- For Leukocyte Differential Counts: Most likely established through expert manual microscopy following established laboratory protocols. This often involves reviewing stained blood smears by trained morphologists, potentially with consensus if multiple reviewers are used.
The sample size for the training set:
- Not specified.
- Note: Automated hematology analyzers are typically developed and "trained" (i.e., their algorithms are optimized) using a diverse and large set of patient samples to ensure robust performance across various physiological and pathological conditions.
How the ground truth for the training set was established:
- Similar to the test set, the ground truth for the training set would have been established through a combination of reference methods for quantitative parameters and expert manual microscopy for leukocyte differentials. This iterative process of running samples, having experts determine the "true" values, and then refining the device's algorithms is standard in the development of such automated systems.

Summary

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K032013

Summary of Safety and Effectiveness for COULTER® AcT™ 5diff Autoloader (AL) Hemalogy Analyzer with Version 1.10 Software

1.0 General Information

Device Generic Name(s): Automated differential cell counter

COULTER® AcT™ 5diff AL Hematology Analyzer Device Trade Name(s): The COULTER® AcT™ 5diff AL Hematology Device Classification: Analyzer is a Class II medical device.

Beckman Coulter, Inc. Applicant Name and Address: Cellular Analysis Division 11800 SW 147 Avenue Miami, FL 33196-2500

June 27, 2003 Date:

2.0 Legally Marketed Device(s)

The modified COULTER® AcT™ 5diff AL Hematology Analyzer with Version 1.10 Software claims substantial equivalence to the previously cleared COULTER® AcT™ 5diff AL Hematology Analyzer with Version 1.00 Software. FDA 510 (k) Number: K030291

The use of a second predicate device the COULTER® LH 750 Hematology Analyzer was used to show substantial equivalence of the extended Platelet Count linearity capability. FDA 510(k) Number: K022161.

3.0 Device Description

The AcT™ 5diff AL provides automated complete blood counts (CBC) and leukocyte differential counts.

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The following reagents, with 510(k) numbers indicated where applicable, are qualified for use on the COULTER® AcT™ 5diff AL Hematology Analyzer with Version 1.10 software:

Reagent	FDA Docket
COULTER® AcT™ 5diff Diluent -- used in the dilutionof blood for counting and differentiation of cells.	Class I Exempt
COULTER® AcT™ 5diff WBC Lyse - used to lyseRBC for WBC enumeration and differentiation	Class I Exempt
COULTER® AcT™ 5diff Fix - used to lyse RBC, fixand differentially stain WBC	Class I Exempt
COULTER® AcT™ 5diff Hgb Lyse - used to lyse RBCfor hemoglobin determination	Class I Exempt
COULTER® AcT™ 5diff Rinse - enzymatic solutionfor rinsing	Class I Exempt

Calibrator and Control	FDA Docket
COULTER® AcT™ 5diff Control Plus control –manufactured and labeled for BCI by R&D Systems Inc.	K003534
COULTER® AcT™ 5diff Cal calibrator - manufacturedand labeled for BCI by R&D Systems Inc.	K912357

Principle of Method: 4.0

The Beckman Coulter, Inc. (BCI) Coulter® Ac•T™ 5diff Autoloader Hematology Analyzer (AcT™ 5diff AL) is a bench top laboratory instrument, designed for In Vitro Diagnostic Use in clinical laboratories, capable of analyzing samples in a closed vial Autoloader mode or a Stat mode (open or closed vial).

The AcT™ 5diff AL provides automated complete blood counts (CBC) and leukocyte differential counts. 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.

The CBC analysis is based on the established Coulter Principle of automated cell counting and spectrophotometric hemoglobin determination.

The differential analysis uses the princibles of aperture impedance, cvtochemistry, focused flow impedance, and light transmission from a halogen light source.

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The instrument is microprocessor driven with a PC that performs data processing and data management activities.

5.0 Indications for Use:

The COULTER® AcT™ 5diff AL hematology analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.

Description of the modification: 6.0

The currently marketed COULTER® AcT™ 5diff AL hematology analyzer with Version 1.00 software release was modified with software changes to improve performance characteristics and provide additional Workstation functionality.

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 4 2003

Ms. Lourdes Coba Senior Regulatory Affairs Specialist Beckman Coulter, Inc. Cellular Analysis Division 11800 SW 147 Avenue Miami, FL 33196-2500

Re: K032013

Trade/Device Name: COULTER® AcT™ Sdiff AL Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: June 27, 2003 Received: June 30, 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). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

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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INDICATIONS FOR USE

510(k) Number (if known):

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

Indications For Use:

The COULTER® AcT™ 5diff AL Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.

21 CFR 864.5220 Automated differential cell counter

An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.

intere of . Michan () mis. FOR ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ BAUTOSTA Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

(PLEASE DO NOT WRITE BE ONTINUE 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

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.”