COULTER ACT TRON CELL CONTROL by COULTER CORP.

COULTER® ALT TRON Cell Control is intended For In Vitro Diagnostic Use as a control to monitor the performance of the CBC parameters on COULTER® A · T Series Systems. Instrument performance is monitored using the assigned ranges on the TABLE OF EXPECTED RESULTS and reagents designed by Coulter for these systems.

Device Description

The product is a Hematology Quality Control Mixture which like the predicate device, COULTER® 4C® PLUS Cell Control, is used to monitor the performance of Coulter hematology analyzers. COULTER® A °T TRON Cell Control is prepared from stabilized erythrocytes and a red chromophore so that repeated measurements can be made to monitor daily performance of the instrument system. Assigned values are confirmed by multiple analyses of the control product.

AI/ML Overview

The provided text describes the COULTER® A.T TRON Cell Control, a hematology quality control mixture, and its nonclinical testing. However, it does not contain a detailed study report that would allow for a comprehensive description of acceptance criteria and a study proving device performance in the way typically expected for a medical device clinical trial or performance study on patient data.

The document is a 510(k) summary for a diagnostic control product, which focuses on demonstrating substantial equivalence to a predicate device based on its intended use, technological characteristics, and performance for its specific function (monitoring instrument accuracy). The "study" mentioned here refers to nonclinical testing of the control solution itself, not a clinical study involving patient samples or human readers.

Here's an attempt to extract and present the information based on the provided text, acknowledging its limitations for certain categories:

Acceptance Criteria and Device Performance for COULTER® A.T TRON Cell Control

The COULTER® A.T TRON Cell Control is a hematology quality control mixture intended for In Vitro Diagnostic Use as a control to monitor the performance of CBC parameters on COULTER® A.T Series Systems. The "study" described is nonclinical testing focused on the performance characteristics of the control solution itself, specifically its homogeneity and stability.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Precision	Not explicitly stated in the document, but implied by "replicate measurements."	"Testing met all acceptance criteria for the following: precision tested by replicate measurements..."
Stability	Recovery of values within the Assigned Ranges (Table of Expected Results on the package insert).	"Testing met all acceptance criteria for the following: ...stability tested by recovery of values within the Assigned Ranges..."
Intended Use	Monitor the performance of CBC parameters on COULTER® A.T Series Systems using assigned ranges.	The device has the same intended use as the predicate device (COULTER® 4C® PLUS Cell Control). This implies it performs its monitoring function effectively.

Missing Information:

Specific numerical acceptance criteria for precision (e.g., CV% less than X%).
Specific numerical acceptance criteria for stability (e.g., drift within Y% over Z days).
Details of the "Table of Expected Results" (e.g., target values and ranges for various CBC parameters).

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

Sample Size: Not explicitly stated for the nonclinical testing. The text mentions "replicate measurements" for precision and "recovery of values" for stability, implying multiple tests were performed on the control solution.
Data Provenance: Not applicable in the context of a clinical study with patient data. This is nonclinical testing of a manufactured control product.

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

Not Applicable. The "ground truth" for this product is its own inherent stability and precision as a manufactured control, defined by its expected ranges and performance characteristics. There is no human expert "ground truth" generation for diagnostic interpretations in this context, as it's a quality control material, not a diagnostic device interpreting patient data.

4. Adjudication Method for the Test Set

Not Applicable. As there are no human experts interpreting results and no diagnostic decisions being made, an adjudication method is irrelevant.

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

No. This type of study is for evaluating the reader performance of diagnostic devices (e.g., AI algorithms for image analysis) and comparing human performance with and without AI assistance. The COULTER® A.T TRON Cell Control is a quality control substance for hematology analyzers, not a diagnostic device for human interpretation, thus an MRMC study is not relevant or performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

N/A (Not an algorithm). This device is a biochemical control solution, not an algorithm. Standalone performance studies typically refer to the performance of AI algorithms without human intervention.

7. Type of Ground Truth Used

The "ground truth" for this product's performance is established by assigned values and expected ranges derived from extensive testing during its development and manufacturing, likely using reference methods or highly calibrated instruments. The product itself is the control 'truth' against which analyzer performance is measured. The text mentions "Assigned values are confirmed by multiple analyses of the control product."

8. Sample Size for the Training Set

Not Applicable. This device is not an AI algorithm that requires a "training set" of data.

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

Not Applicable. As there is no training set mentioned, this question is not relevant.

Summary

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K971469

510(k) Summary COULTER® AºT TRON Cell Control

JUN 30 1997

Date of Summary:

Coulter Corporation, Company/Institution name: 11800 SW 147 Ave. Miami, FL 33196, Mailcode 31-B06 Thomas J. English, Phone 1-305-380-4331 Contact Name:

April 16, 1997

Common or usual name or classification name: Hematology Quality Control Mixture COULTER® A . T TRON Cell Control Product name: 864.8625 C.F.R. Section: Device Class: Class II

510(k) numbers of Coulter devices to which substantial equivalence is claimed: COULTER® 4C® PLUS Cell Control, K964988

Intended Use: COULTER® AST TRON Cell Control is intended For In Vitro Diagnostic Use as a control to monitor the performance of the CBC parameters on the COULTER® A . T Series Systems. Instrument performance is monitored using the assigned ranges on the TABLE OF EXPECTED RESULTS and reagents designed by Coulter for these systems.

COULTER A . T TRON Cell Control has the same intended use as the predicate device. Both devices are used to monitor instrument performance. Both devices consist of stabilized erythrocytes and a platelet-sized component suspended in a bacteriostatic medium. Both have assigned values which are confirmed by multiple analyses of the control product.

The differences between COULTER A T TRON cell control and COULTER 4C PLUS Cell Controls are: COULTER A T TRON cell control utilizes a red chromophore measured spectrophotometrically to simulate hemoglobin. COULTER A . T TRON cell control monitors the lytic reagent but does not monitor the potency of the lytic reagent. The predicate device in the presence of lytic reagent forms a Met-Hgb complex which is measured spectrophotometrically. COULTER 4C PLUS Cell Control monitors both the volume and potency of the lytic reagent.

Nonclinical testing focused on performance characteristics of homogeneity and stability. Testing met all acceptance criteria for the following: precision tested by replicate measurements and stability tested by recovery of values within the Assigned Ranges (Table of Expected Results on the package insert).

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is written in a simple, sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Thomas J. Enqlish Director, Regulatory Affairs Coulter Corporation P.O. Box 169015 Miami, Florida 33116-9015

JUN 30 1997

K971469 Re: COULTER® A°.T Tron Cell Control Requlatory Class: II Product Code: . JPK Dated: April 18, 1997 Received: April 22, 1997

Dear Mr. English:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): N/A

Device Name: COULTER®ALT TRON Cell Control

Indications For Use:

more TER® A · T TRON Cell Control is intended For In Vitro Diagnostic Use as a control to monitor the performance of the CBC parameters on COULTER® A · T Series Systems. Instrument performance is monitored using the assigned ranges on the TABLE OF EXPECTED RESULTS and reagents designed by Coulter for these systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_L (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Form 1-2-96)

Patricia A. Bernhardt,
(for Awm) 6/26/97

K97449

Regulation Number and Section

§ 864.8625 Hematology quality control mixture.

(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.