PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2

K994045 · Primus Corp. · LCP · Dec 21, 1999 · Hematology

Device Facts

• Record ID: K994045
• Device Name: PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
• Applicant: Primus Corp.
• Product Code: LCP · Hematology
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

In vitro diagnostic use to establish reference points for glycated hemoglobin test methods

Device Story

Primus Liquid Calibrators for GHb/A1c (Level 1 and Level 2) are in vitro diagnostic products used in clinical laboratory settings. These calibrators provide reference points to calibrate and standardize glycated hemoglobin (GHb/A1c) test methods. By establishing these reference points, the device ensures the accuracy and consistency of patient hemoglobin A1c measurements, which are critical for monitoring long-term glycemic control in patients with diabetes. The calibrators are intended for professional use by laboratory personnel.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid-based calibrator solution for in vitro diagnostic use. Designed for standardization of GHb/A1c assays. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for in vitro diagnostic use to establish reference points for glycated hemoglobin test methods.

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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Public Health Service

## DEC 2 1 1999

Jim Noffsinger, Ph.D. Vice President, Research and Development Primus Corporation 7235 Central P.O. Box 22599 Kansas City, Missouri 64113

Re: K994045

Trade Name: Primus Liquid Calibrators for GHb/A1c Level 1 and Level 2 Regulatory Class: II Product Code: LCP Dated: November 23, 1999 Received: November 29, 1999

## 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 (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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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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 [phone].

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"(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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/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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## INDICATIONS FOR USE STATEMENT

| 510(k) Number: | K994045 |
|----------------------|-----------------------------------------------------------------------------------------------|
| Device Name: | Primus Liquid Calibrators 1 and 2 for GHb/A1c |
| Indications For Use: | In vitro diagnostic use to establish reference points for<br>glycated hemoglobin test methods |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994045

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PO Box 22599 Kansas City, MO 64113 816-523-7491 FAX: [phone]