ATAC HEMOGLOBIN A1C REAGENT KIT by CLINICAL DATA, INC.

The ATAC Hemoglobin A1C Reagent Kit is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of Hemoglobin A1C results are used to assess the level of control of a patient's diabetes.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Device Description

The ATAC HemoglobinAlC Reagent Kit is intended for the quantitative determination of HemoglobinA1C in whole blood. HemoglobinA1Cresults are used in monitoring glycemic control in diabetic patients. The assay determines total hemoglobin and umole A1C. These values are then used in the calculation of %Hemoglobin A1C reagent is substantially equivalent to the Bayer HemoglobinA1C reagent, Bayer product no. T01-3639-01, cuttently marketed by Bayer Corporation, Tarrytown, New York.

AI/ML Overview

The provided text describes the ATAC HemoglobinA1C Reagent Kit and studies performed to demonstrate its effectiveness. Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The text doesn't explicitly state "acceptance criteria" for precision or method comparison in a pass/fail format. Instead, it presents the results of these studies. The "acceptance criteria" are implied by the performance statistics themselves, specifically that the results fall within generally accepted ranges for such assays or are comparable to the predicate device.

Study Type	Acceptance Criteria (Implied)	Reported Device Performance
Precision	%CV values within acceptable limits for HbA1c assays.	Control 1: %CV (Within Run) = 3.38%, %CV (Total) = 4.74%
		Control 2: %CV (Within Run) = 2.46%, %CV (Total) = 3.08%
		Patient: %CV (Within Run) = 2.60%, %CV (Total) = 4.66%
Method Comparison	Strong linear correlation and agreement with a comparative method (TOSOH HPLC). Slope close to 1, intercept close to 0.	ATAC 8000 = 0.6367 + 0.9722 x Comparative Method
Calibration Stability	Total imprecision of %HemoglobinA1C recoveries over claimed period < 5%.	Less than 5% total imprecision over 12 days.
On-board Stability	Total imprecision of %HemoglobinA1C recoveries over claimed period < 5%.	Less than 5% total imprecision over 10 days.

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

Precision Study:
- Control 1: n = 32
- Control 2: n = 31
- Patient Sample: n = 31
- Data Provenance: Not explicitly stated, but likely from a laboratory setting as part of a validation study. The patient sample is described as "pooled patient sample," suggesting it's from clinical samples.
Method Comparison Study:
- Sample Size: Not explicitly stated in the provided text. It mentions comparing "Whole blood samples collected from patients."
- Data Provenance: "Whole blood samples collected from patients." This indicates prospective clinical samples. Country of origin is not specified.

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

This information is not applicable to this type of device. The ATAC HemoglobinA1C Reagent is a laboratory diagnostic assay, and its performance is evaluated against established analytical methods (like TOSOH HPLC for method comparison) and controls, not subjective expert assessment of images or clinical opinions.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers when establishing ground truth, typically in image-based diagnostic or clinical assessment studies. This device's performance is measured by quantitative analytical results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers assessing cases with and without AI assistance, which is irrelevant for a quantitative diagnostic reagent.

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

Yes, the studies described are standalone performance evaluations of the ATAC HemoglobinA1C Reagent Kit on the ATAC 8000 Random Access Chemistry System. This device is an automated in vitro diagnostic (IVD) assay; its performance is inherently "standalone" in that it produces a quantitative result without direct human interpretation of, for example, an image, which would then be compared to a human's interpretation. The "algorithm" here refers to the chemical reactions and photometric measurements performed by the system.

7. The Type of Ground Truth Used

For Precision: The ground truth is the inherent stability and reproducibility of the assay when run repeatedly on stable samples (controls and pooled patient sample).
For Method Comparison: The ground truth is established by a comparative method, specifically the TOSOH HPLC method, which is a widely accepted and established reference method for HbA1c determination.
For Linearity, Calibration Stability, and On-board Stability: Ground truth is established by the expected behavior of known calibrators and controls over time and across concentration ranges.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. The ATAC HemoglobinA1C Reagent Kit is a chemical assay, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a system involves calibrating the instrument with known standards and optimizing the reagent formulation and assay parameters based on extensive R&D and analytical validation. The document does not describe a machine learning component that would have a distinct training set.

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

As noted above, the concept of a "training set" and associated "ground truth" establishment in the machine learning sense is not applicable to this medical device. The 'ground truth' for developing such a reagent would stem from comprehensive chemical and analytical validation, using reference materials, established laboratory practices, and comparisons to recognized analytical methods during the research and development phase.

Summary

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NOV - 3 2003

October 30, 2003

Device Name:

ATAC HemoglobinA1C Reagent

K031042

Summary of 510(k) Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The effectiveness of the ATAC HemoglobinA1C Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.

Analyzing A1C calibrators run as unknowns validated Bayer linearity claims. Total hemoglobin linearity was validated using hemolysates that spanned the range of zero to 23 g/dL.

Precision is demonstrated by the replicate assay of Bayer DCA 2000 Controls and a pooled patient sample. Precision statistics, calculated analogous to the methods described in NCCLS Guideline EP-6P, are shown below.

Sample	n	mean	Within Run		Total
			1SD	%CV	1SD	%CV
Control 1	32	5.581	0.189	3.38	0.265	4.74
Control 2	31	10.345	0.254	2.46	0.318	3.08
Patient	31	6.777	0.176	2.60	0.316	4.66

Whole blood samples collected from patients and were assayed using the ATAC 8000 Random Access Chemistry System and by TOSOH HPLC method. Results were compared by least squares linear regression and the following statistics were obtained.

ATAC 8000 = 0.6367 + 0.9722 x Comparative Method

The 12 day calibration stability claim and 10 day on board stability claim are documented through the assay of controls and a pooled patient sample over the claimed periods. In all cases, the total imprecision of %HemoglobinA1C recoveries over the test periods are less than 5%.

Wymun Strahn

Wynn Stocking
Manager, Regulatory Affairs
Clinical Data, Inc.
Brea, California
714-672-3553

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Image /page/1/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 that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 3 2003

Mr. Wynn Stocking Manager, Regulatory Affairs Clinical Data, Inc. 1075 W. Lambert Road Building D Brea, CA 92821

Re: K031042

Trade/Device Name: ATAC HemoglobinA1C Reagent Regulation Number: 21 CFR 864. 7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: August 6, 2003 Received: August 7, 2003

Dear Mr. Stocking:

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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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 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): K031042

Device Name:

ATAC Hemoglobin A 1C Reagent

Indications for Use:

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

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

Concurrence of CDRH, Office of Device Evaluation (PDE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Carol C. Benam for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K03/042

Regulation Number and Section

§ 864.7470 Glycosylated hemoglobin assay.

(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).