CREATINE KINASE-MB REAGENT SET

K971566 · Horizon Diagnostics, Inc. · CGS · Jul 14, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971566
• Device Name: CREATINE KINASE-MB REAGENT SET
• Applicant: Horizon Diagnostics, Inc.
• Product Code: CGS · Clinical Chemistry
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

For in vitro diagnostic use in the quantitative determination of creatine kinase-MB in recommended when Acute Myocardial Infarction is suspected.

Device Story

Creatine Kinase-MB (CK-MB) Reagent Set used for in vitro diagnostic quantitative determination of CK-MB levels in clinical laboratory settings. Device assists clinicians in the diagnosis of suspected Acute Myocardial Infarction. Operates via chemical reagent interaction to measure enzyme activity; results provided to healthcare providers to inform clinical decision-making regarding cardiac events.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the reagent set.

Technological Characteristics

In vitro diagnostic reagent set for quantitative enzymatic determination of CK-MB. Class II device, product code CGS.

Indications for Use

Indicated for in vitro diagnostic quantitative determination of creatine kinase-MB in patients suspected of having an Acute Myocardial Infarction.

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.

Reference Devices

• Kaplan, I.A. and Pesce, AJ.: Clinical Chemistry. St. Louis, C.V. Mosby Co., pp. 490-503 (1984)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

David L. Callender Official Correspondent Horizon Diagnostics, Inc. . . 3660 Plaza Drive, Suite 4 Ann Arbor, Michigan 48108

JUL 1 4 1997

K971566 Re : Creatine Kinase-MB Reagent Set Regulatory Class: II Product Code: CGS Dated: June 25, 1997 June 30, 1997 Received:

Dear Mr. Callender:

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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlation 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 Requlations.

{1}------------------------------------------------

Page 2

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 requlation (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

{2}------------------------------------------------

HORIZON DIAGNOSTICS

Page 1 of 1

510 (k) Number (if known): Device Name:

K971566 Creatine Kinase-MB Reagent Set

## INDICATIONS FOR USE

For in vitro diagnostic use in the quantitative determination of creatine kinase-MB in recommended when Acute Myocardial Infarction is suspected.

Ref: Kaplan, I.A. and Pesce, AJ.: Clinical Chemistry. St. Louis, C.V. Mosby Co., pp. 490-503 (1984).

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number,
K971566

(FLEASE 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)