ABBOTT ARCHITECT GLYCATED HEMOGLOBIN by ABBOTT LABORATORIES

The Abbott ARCHITECT™ Glycated Hemoglobin assay is a boronate affinity binding assay intended to measure glycated hemoglobin in human anticoagulated whole blood. Measurement of glycated hemoglobin is used for the management of diabetes mellitus.

Device Description

The ARCHITECT™ Glycated Hemoglobin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of glycated hemoglobin in human anticoagulated whole blood (EDTA, lithium heparin, or sodium heparin). The ARCHITECTTM Glycated Hemoglobin assay is calibrated with Abbott ARCHITECT™ Glycated Hemoglobin Calibrators. Abbott ARCHITECT™ Glycated Hemoglobin Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Abbott ARCHITECT™ Glycated Hemoglobin assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Abbott ARCHITECT™ Glycated Hemoglobin assay are implicitly defined by its demonstration of substantial equivalence to the Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System (K851636). The performance metrics used for this comparison were based on regression analysis.

Acceptance Criteria (Implied)	Reported Device Performance (ARCHITECT™ Glycated Hemoglobin vs. Bio-Rad DIAMAT™)
Correlation (r): High correlation to predicate device	0.961
Slope (Least Squares): Close to 1.0	0.96 (95% CI: 0.93, 1.00)
Intercept (Least Squares): Close to 0	0.42 (95% CI: 0.15, 0.68)
Slope (Passing-Bablok): Close to 1.0	1.00 (95% CI: 1.00, 1.06)
Intercept (Passing-Bablok): Close to 0	0.20 (95% CI: -0.27, 0.20)
Measurement Range Coverage: Equivalent to predicate device	Specimens ranged from 4.3 to 14.3 %A1c eq (ARCHITECT™) and 4.4 to 14.5 %A1c (Bio-Rad DIAMAT™)

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

Sample Size for Test Set: 249
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved human anticoagulated whole blood specimens. It is retrospective in the sense that existing specimens were analyzed and compared.

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

Number of Experts: Not applicable. This study does not rely on human experts to establish ground truth in the traditional sense of image interpretation or diagnostic review.
Qualifications of Experts: Not applicable. The "ground truth" is established by the predicate device's measurements.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This is a comparison study between two quantitative laboratory assays. There is no human adjudication process involved; the comparison is statistical.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This is a comparison of two laboratory devices, not a study involving human readers' diagnostic performance.

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

Standalone Performance: Yes, the entire study is focused on the standalone performance of the Abbott ARCHITECT™ Glycated Hemoglobin assay. It's a fully automated in vitro diagnostic device, and its performance is evaluated independently of human intervention in the measurement process.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this study is effectively established by the results obtained from the legally marketed predicate device, the Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System. The goal is to demonstrate that the new device's measurements correlate strongly and are in agreement with those of the established predicate device.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The provided text describes a validation study for a medical device (an in vitro diagnostic assay), not a machine learning algorithm that requires a training set. The device's calibration and control systems are mentioned, but these are distinct from a "training set" in the context of AI/ML.

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

Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of this device's validation as presented. The device is calibrated using Abbott ARCHITECT™ Glycated Hemoglobin Calibrators, but the method for establishing the ground truth of these calibrators is not detailed in the provided summary.

Summary

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510(k) Summarv Abbott ARCHITECTTM Glycated Hemoglobin

Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the Premarket Notification [510(k)] for Abbott ARCHITECT™ Glycated Hemoglobin constitutes data supporting a substantially equivalent determination.

Substantial equivalence has been demonstrated between the ARCHITECT™ Glycated Hemoglobin assay and the Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System (K851636). The intended use of the ARCHITECTTM Glycated Hemoglobin assay is for the quantitative determination of glycated hemoglobin in human anticoagulated whole blood using a boronate affinity binding immunoassay. The intended use of the Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System is for the quantitative determination of glycated hemoglobin in human anticoagulated whole blood using ion exchange high performance liquid chromatography (HPLC).

Sample	Regression Method	n	r	Slope (95%CI)	Intercept (95% CI)
Whole Blood	Least Squares	249	0.961	0.96 (0.93, 1.00)	0.42 (0.15, 0.68)
	Passing-Bablok	249	0.961	1.00 (1.00, 1.06)	0.20 (-0.27, 0.20)

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In this evaluation, human anticoagulated whole blood specimens tested ranged from 4.3 to 14.3 %A1c eq with the ARCHITECT™ Glycated Hemoglobin assay and from 4.4 to 14.5 %A1c with the Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System.

In conclusion, these data demonstrate that the ARCHITECT™ Glycated Hemoglobin assay is as safe and effective as, and is substantially equivalent to, the Bio-Rad DIAMATTM Glycosylated Hemoglobin Analyzer System.

Prepared and Submitted April 27, 1999 by:

Katherine M. Wortley, Ph.D. Regulatory Specialist ADD Regulatory Affairs (847) 938-7707 Bldg. AP31, Dept. 9V6 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-6200

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 1 1999

Katherine M. Wortley, Ph.D. Regulatory specialist ADD Regulatory Affairs Abbott Laboratories Bldg. AP31. Dept. 9V6 200 Abbott Park Road Abbott Park, Illinois 60064-3537

K991483 Re:

Trade Name: Abbott ARCHITECT™ Glycated Hemoglobin Regulatory Class: II Product Code: LCP Dated: August 2, 1999 Received: August 3, 1999

Dear Dr. Wortley:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.

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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 regulation (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.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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510(k) Number (if known): $991483 Device Name: Abbott ARCHITECT™ Glycated Hemoglobin

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991483

Prescription Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
OR
Over-The-Counter Use__

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).