The Abbott IMx® Glycated Hemoglobin II assay is an Ion Capture Assay intended to measure glycated hemoglobin in human anticoagulated whole blood. Measurement of glycated hemoglobin is used in the management of diabetes mellitus.

Device Description

The Abbott IMx Glycated Hemoglobin II assay is a boronate affinity binding assay using Ion Capture separation for the quantitative determination of percent glycated-hemoglobin in human anticoagulated whole blood (EDTA, lithium heparin, or sodium heparin) on the Abbott IMx analyzer. Glycated hemoglobin measurements are used in the management of diabetes mellitus. The Abbott IMx Glycated Hemoglobin II assay is calibrated with Abbott IMx Glycated Hemoglobin II Calibrators. Abbott IMx Glycated Hemoglobin II Controls are assayed for the verification of the accuracy and precision of the Abbott IMx Analyzer.

AI/ML Overview

This document describes the acceptance criteria and study proving the Abbott IMx® Glycated Hemoglobin II device meets those criteria, based on the provided 510(k) summary (K992085).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Abbott IMx® Glycated Hemoglobin II assay is demonstrating substantial equivalence to the predicate device, the Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System. This was assessed through a correlation study.

Acceptance Criteria (based on predicate device comparison)	Reported Device Performance (IMx® Glycated Hemoglobin II vs. Bio-Rad DIAMAT™)
Intended Use: Quantitative determination of glycated hemoglobin in human anticoagulated whole blood.	Both devices share the same intended use.
Analyte Measured: Glycated Hemoglobin (%A1c)	Both devices measure Glycated Hemoglobin, %A1c. The IMx device also reports %GHb.
Assay Principle: (Not a direct acceptance criterion, but part of comparison)	IMx uses Boronate affinity Ion Capture (Predicate uses Ion exchange liquid chromatography - HPLC).
Instrumentation: (Not a direct acceptance criterion, but part of comparison)	IMx uses IMx Analyzer (Predicate uses DIAMAT Analyzer System).
Standardization: Traceable to DCCT reference method; Certified via NGSP.	Both devices are traceable to DCCT and certified via NGSP.
Sample Type: Human anticoagulated whole blood.	Both devices use human anticoagulated whole blood (IMx: EDTA, lithium heparin, sodium heparin; Predicate: EDTA, potassium oxalate, sodium fluoride).
Correlation with Predicate Device (demonstrating substantial equivalence):	Regression Method: Least Squares n: 247 r: 0.976 Slope: 0.94 Intercept: 0.45
	Regression Method: Passing-Bablok n: 247 r: 0.976 Slope: 0.98 Intercept: 0.13

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

Sample Size: 247
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective.

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

This type of study for a Glycated Hemoglobin assay typically relies on comparison to a reference or predicate method, not expert interpretation of results. Therefore, the concept of "experts establishing ground truth" in the diagnostic imaging sense does not directly apply here. The "ground truth" for the comparison is the result obtained from the predicate device (Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System), which is itself a validated diagnostic assay.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the study compared results to a predicate device, not through an adjudication process of subjective interpretations.

5. 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

Not applicable. This is a diagnostic assay, not an AI-assisted diagnostic imaging device with human readers.

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

Yes, the study is a standalone performance assessment of the Abbott IMx® Glycated Hemoglobin II assay in comparison to the predicate device. The assay performs its measurement and provides a result without human interpretation of raw data in the sense of an imaging study.

7. The Type of Ground Truth Used

The "ground truth" for the correlation study was the quantitative results generated by the predicate device, the Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System. This is a form of comparison to an established and legally marketed diagnostic device. The predicate device itself is standardized and certified via the National Glycohemoglobin Standardization Program (NGSP) and traceable to the Diabetes Control and Complications Trial (DCCT) reference method.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its size. In the context of an in-vitro diagnostic assay validation, the focus is typically on the performance of the final assay against established methods rather than an iterative machine learning training process.

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

Not applicable, as a distinct "training set" and its associated ground truth establishment methods are not described in this 510(k) summary for this type of device. The assay's method is based on established chemical principles (boronate affinity binding) rather than statistical learning from a large training dataset.

Summary

{0}------------------------------------------------

K992085

510(k) Summary

Abbott IMx ® Glycated Hemoglobin II

Submitter: Abbott Laboratories Abbott Diagnostics Division 200 Abbott Park Road Abbott Park, IL 60064 (847) 938-7707

Contact Person: Katherine M. Wortley

Date Prepared: April 26, 2000

Product Trade and Common Name: Abbott IMx ® Glycated Hemoglobin II

Classification Name: Class II, 81LCP 21 CFR 864.7470 Glycosylated Hemoglobin Assay

Predicate Device:

Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System (K851636)

Description and Intended Use of the Device:

Responses Page 51

{1}------------------------------------------------

Technical Characteristics Compared to Predicate:

The technical characteristics of the two systems are presented in the table below:

Assay Characteristics	Bio-Rad DIAMAT™Glycosylated HemoglobinAnalyzer System	IMx® GlycatedHemoglobin II
Analyte Measured: Reported	Glycated Hemoglobin: %A1c	Glycated Hemoglobin: %A1cand %GHb
Assay Principle	Ion exchange liquidchromatography (HPLC)	Boronate affinity Ion Capture
Instrumentation	DIAMAT Analyzer System	IMx Analyzer
Standardization	Traceable to the DiabetesControl and Complications Trial(DCCT) reference method.Certified via the NationalGlycohemoglobinStandardization Program(NGSP).	Traceable to the DiabetesControl and ComplicationsTrial (DCCT) referencemethod. Certified via theNational GlycohemoglobinStandardization Program(NGSP).
Sample Type	Human anticoagulated wholeblood (EDTA, potassiumoxalate or sodium fluoride).	Human anticoagulated wholeblood (EDTA, lithiumheparin, and sodium heparin)

Testing to Establish Substantial Equivalence:

Substantial equivalence has been demonstrated between the IMx Glycated Hemoglobin II assay and the Bio-Rad DIAMAT Glycosylated Hemoglobin Analyzer System. The intended use for both the IMx Glycated Hemoglobin II assay and the Bio-Rad DIAMAT Glycosylated Hemoglobin Analyzer System is the quantitative determination of glycated hemoglobin in human anticoagulated whole blood. A correlation study was done to compare the two assays. The results are presented in the following table:

Regression Method	n	r	Slope	Intercept
Least Squares	247	0.976	0.94	0.45
Passing-Bablok	247	0.976	0.98	0.13

Conclusion:

In conclusion, these data demonstrate that the IMx Glycated Hemoglobin II is substantially equivalent to, the Bio-Rad DIAMAT Glycosylated Hemoglobin Analyzer System.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the upper half of the circle.

MAY 2 5 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Katherine M. Wortley, Ph.D. Senior Regulatory Specialist ADD Regulatory Affairs Bldg. AP31, Dept. 9YC 200 Abbott Park Road Abbott Park, Illinois 60064-6200

Re: K992085 Trade Name: Abbott Imx Glycated Hemoglobin II Regulatory Class: II Product Code: LCP Dated: April 26, 2000 Received: April 27, 2000

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 (QS) 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.

{3}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to oceni marketing your device of your device to a legally marketed nothication. The PDF mainly of backantar vqur device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and IT you desire specific advices your ostic devices), please contact the Office of Compliance at additionally 807.10 for mire alleghestions on the promotion and advertising of your device, (201) 594-4588. Addinonally, 18. quee at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionals and institute and more (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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known):

Device Name: ________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	OR	Over-The-Counter Use ______
(Per 21 CFR 801.109)		(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K972085

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).