NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY

K993131 · Primus, Inc. · LCP · May 22, 2000 · Hematology

Device Facts

• Record ID: K993131
• Device Name: NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
• Applicant: Primus, Inc.
• Product Code: LCP · Hematology
• Decision Date: May 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

NycoCard HbA1c is a laboratory test intended for the quantitative determination of percent glycated hemoglobin in whole blood using the system to monitor long term blood glucose control in individuals with diabetes mellitus.

Device Story

NycoCard HbA1c is an in vitro diagnostic assay for quantitative measurement of glycated hemoglobin in whole blood. Used to monitor long-term glycemic control in diabetic patients. System provides quantitative results to clinicians to assess glucose management over time. Not intended for diabetes diagnosis due to potential for false results.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

In vitro diagnostic assay for quantitative determination of glycated hemoglobin. System-based measurement.

Indications for Use

Indicated for the quantitative determination of percent glycated hemoglobin in whole blood to monitor long-term blood glucose control in individuals with diabetes mellitus. Not indicated for the diagnosis 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.

Submission Summary (Full Text)

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## MAY 2 2 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jim Noffsinger, Ph.D. Vice President Research Primus Corporation P.O. Box 22599 Kansas City, Missouri 64113

Re: K993131

> Trade Name: NycoCard® HbA1c Glycated Hemoglobin Assay Regulatory Class: II Product Code: LCP Dated: April 11, 2000 Received: April 13, 2000

Dear Dr. Noffsinger:

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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance 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 Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Toutman

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 STATEMENT

| 510(k) Number: | K992921 K993131 |
|----------------------|--------------------------------------------------------------------------|
| Device Name: | NycoCard HbA1c |
| Indications For Use: | Measurement of Glycohemoglobin in blood.<br>In vitro diagnostic use only |

NycoCard HbA1c is a laboratory test intended for the quantitative determination of percent glycated hemoglobin in whole blood using the system to monitor long term blood glucose control in individuals with diabetes mellitus.

Conditions for use:

The measurement of glycohemoglobin has not been shown to be reliable in the diagnosis of diabetes mellitus. Such use yields too many false negative and false positive results. (see Lester E. "The clinical value of glycated hemoglobin and glycated plasma proteins". Ann Clin Biochem 19989;26:213-9)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Esther Makim

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K993131 |

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)