CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30

K973999 · Diagnostic Chemicals , Ltd. · CGS · Mar 11, 1998 · Clinical Chemistry

Device Facts

• Record ID: K973999
• Device Name: CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: CGS · Clinical Chemistry
• Decision Date: Mar 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

For the quantitative determination of creatine kinase in serum. For IN VITRO diagnostic use.

Device Story

Creatine Kinase-SL Assay is an in vitro diagnostic reagent kit used for the quantitative measurement of creatine kinase (CK) levels in human serum. The assay is intended for use in clinical laboratory settings by trained laboratory personnel. It utilizes a chemical reaction to measure CK activity, which is then used by clinicians to assess muscle tissue damage, such as in myocardial infarction or skeletal muscle disorders. The output is a numerical concentration value of CK in the serum sample, which assists healthcare providers in clinical decision-making regarding patient diagnosis and monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent kit for quantitative enzymatic determination of creatine kinase. Operates via chemical reaction in serum samples. Standard laboratory diagnostic assay format.

Indications for Use

Indicated for the quantitative determination of creatine kinase in human serum for in vitro diagnostic use to aid in the diagnosis and monitoring of clinical conditions associated with muscle damage.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 1 1998

Karen Callbeck, R.T.B.Sc. Regulatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0

Re : K973999 Creatine Kinase-SL Assay, Catalogue Number 326-10, 326-30 Regulatory Class: II Product Code: CGS Dated: January 9, 1998 Received: January 20, 1998

Dear Ms. Callbeck:

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 reqistration, 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. ਸ substantially equivalent determination assumes compliance with "-" the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlations.

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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 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 Sitman

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: Creatine Kinase-SL Assay

Indications For Use:

For the quantitative determination of creatine kinase in serum. For IN VITRO diagnostic use.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K97-399

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)