SYNERMED CREATININE REAGENT KIT

K974909 · Synermed Intl., Inc. · CGX · Feb 24, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974909
• Device Name: SYNERMED CREATININE REAGENT KIT
• Applicant: Synermed Intl., Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Feb 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

The Synermed® Creatinine reagent is intended for use in the quantitative determination of creatinine in serum by manual and automated methods.

Device Story

Synermed Creatinine Reagent kit is an in vitro diagnostic reagent for quantitative measurement of creatinine in serum. Used in clinical laboratory settings via manual or automated methods. Provides serum creatinine concentration data to healthcare providers to assist in evaluating renal function and diagnosing conditions like renal impairment. Benefits include clinical assessment of glomerular filtration rates and monitoring of patients with muscle disease or cachexia.

Clinical Evidence

No clinical data provided; device is a standard clinical chemistry reagent.

Technological Characteristics

In vitro diagnostic reagent for creatinine quantification. Utilizes standard chemical assay principles for serum analysis. Compatible with manual and automated laboratory instrumentation.

Indications for Use

Indicated for the quantitative determination of creatinine in serum. Used to assess renal function; elevated levels indicate decreased glomerular filtration. Applicable to patients with suspected renal impairment, muscle disease, or cachexia.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 4 1998

Marcia Arentz Vice President, Operations Synermed, Inc. 1688 50th Avenue Montreal (Lachine), Quebec Canada H8T 2V5

Re : K974909 V1560 Creatinine Reagent Regulatory Class: _II Product Code: CGX Dated: December 30, 1997 Received: December 31, 1997

Dear Ms. Arentz:

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 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 Requlations, 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 In addition, FDA may publish further announcements action. 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 [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/dsmamain.html".

Sincerely yours,
Steven Gutman

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): _

Device Name: Creatinine Reagent kit

Indications For Use:

The Synermed® Creatinine reagent is intended for use in the quantitative determination of creatinine in serum by manual and automated methods.

Creatinine concentration is increased when the glomerular filtration is decreased. Blood urea rises more steeply than creatinine as renal function declines; with dialysis, urea levels fall more rapidly than creatinine concentration. With severe, permanent renal impairment, urea levels continue to climb while creatinine levels tend to plateau.

Serum creatinine concentration is low in subjects with relatively small muscle mass, patients with muscle disease, amputees, and cachetic patients. A serum creatinine level that would usually be considered normal does not rule out the presence of impaired renal function.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------------------------------------------------|
| Prescription Use | <span style="text-decoration: underline;">✓</span> |
| (Per 21 CFR 801.109) | |
| | OR |
| Over-The-Counter Use | <span style="text-decoration: underline;"> </span> |
| | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K974909 |