ABBOTT IMX GLYCATED HEMOGLOBIN II

K992085 · Abbott Laboratories · LCP · May 25, 2000 · Hematology

Device Facts

• Record ID: K992085
• Device Name: ABBOTT IMX GLYCATED HEMOGLOBIN II
• Applicant: Abbott Laboratories
• Product Code: LCP · Hematology
• Decision Date: May 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

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 Story

The Abbott IMx Glycated Hemoglobin II is an in vitro diagnostic assay for use on the Abbott IMx analyzer. It utilizes boronate affinity Ion Capture technology to measure percent glycated hemoglobin (%A1c and %GHb) in human anticoagulated whole blood samples. The assay is calibrated using specific IMx Glycated Hemoglobin II Calibrators, with accuracy and precision verified by IMx Glycated Hemoglobin II Controls. The device is intended for use by laboratory professionals to assist in the clinical management of diabetes mellitus. Results are provided to healthcare providers to monitor long-term glycemic control in patients.

Clinical Evidence

Clinical evidence consists of a correlation study comparing the Abbott IMx Glycated Hemoglobin II assay to the Bio-Rad DIAMAT system. The study included 247 samples. Regression analysis showed a correlation coefficient (r) of 0.976, with a slope of 0.94 and intercept of 0.45 (Least Squares), and a slope of 0.98 and intercept of 0.13 (Passing-Bablok).

Technological Characteristics

Boronate affinity Ion Capture assay principle. Analyte: Glycated Hemoglobin (%A1c and %GHb). Sample type: Anticoagulated whole blood (EDTA, lithium heparin, sodium heparin). Standardization: Traceable to DCCT reference method; NGSP certified. Instrumentation: Abbott IMx analyzer.

Indications for Use

Indicated for the quantitative determination of glycated hemoglobin in human anticoagulated whole blood (EDTA, lithium heparin, or sodium heparin) for the management of diabetes mellitus.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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

K992085

#### 510(k) Summary

# Abbott IMx ® Glycated Hemoglobin II

Submitter: Abbott Laboratories Abbott Diagnostics Division 200 Abbott Park Road Abbott Park, IL 60064 [phone]

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:

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.

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™<br>Glycosylated Hemoglobin<br>Analyzer System | IMx® Glycated<br>Hemoglobin II |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte Measured: Reported | Glycated Hemoglobin: %A1c | Glycated Hemoglobin: %A1c<br>and %GHb |
| Assay Principle | Ion exchange liquid<br>chromatography (HPLC) | Boronate affinity Ion Capture |
| Instrumentation | DIAMAT Analyzer System | IMx Analyzer |
| Standardization | Traceable to the Diabetes<br>Control and Complications Trial<br>(DCCT) reference method.<br>Certified via the National<br>Glycohemoglobin<br>Standardization Program<br>(NGSP). | Traceable to the Diabetes<br>Control and Complications<br>Trial (DCCT) reference<br>method. Certified via the<br>National Glycohemoglobin<br>Standardization Program<br>(NGSP). |
| Sample Type | Human anticoagulated whole<br>blood (EDTA, potassium<br>oxalate or sodium fluoride). | Human anticoagulated whole<br>blood (EDTA, lithium<br>heparin, 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, [phone]. Addinonally, 18. quee at [phone]. 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 [phone] or [phone] 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:

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.

(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 | |