CREATINE KINASE REAGENT

K980012 · Ac Biochemicals, Inc. · JHX · Feb 25, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980012
• Device Name: CREATINE KINASE REAGENT
• Applicant: Ac Biochemicals, Inc.
• Product Code: JHX · Clinical Chemistry
• Decision Date: Feb 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Creatine kinase Reagent is to be used in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy.

Device Story

Creatine Kinase Reagent is an in vitro diagnostic reagent used for the quantitative determination of creatine kinase activity in human serum or plasma. Used in clinical laboratory settings by trained laboratory personnel. The reagent facilitates the assessment of cardiac and skeletal muscle conditions, specifically aiding in the diagnosis and monitoring of myocardial infarction and muscle dystrophy. Results are provided to physicians to assist in clinical decision-making regarding patient cardiac and muscular health.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) notification review.

Technological Characteristics

In vitro diagnostic reagent for creatine kinase activity measurement. Class II device (Product Code: JHX).

Indications for Use

Indicated for the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy in patients requiring clinical laboratory evaluation.

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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FEB 25 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Charles C. Allain, Ph.D. .AC Biochemicals, Inc. 17955 Sky Park Circle, Suite J Irvine, California 92614

K980012 Re : Creatine Kinase Reagent Requlatory Class: II Product Code: JHX December 20, 1997 Dated: Received: January 2, 1998

Dear Dr. Allain:

regulations.

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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

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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 Litman

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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80012

510(k) Number (if known):

Device Name: Creatine kinase Reagent

Indications For Use:

The Creatine kinase Reagent is to be used in the assessment of cardiac and skeletal
s and see and states and collection and musele dystrophy The Creatine Knase Reagent is to oc assul in also and muscle dystrophy.
muscle diseases, including myocardial infarction and muscle dystrophy.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K 980012

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

アrescription Use シ (Per 21 CFR 801.109) OR

Over-The-Counter Use

Division
**Confidential**
Division
(H) Num