Creatine Kinase-MB Kit

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K820812 ↗

FDA Product Code

JHY

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Calbiochem-Behring Ria-Count

  Class II

  FDA 510(k) K792460 Active Cleared 13 Feb 1980

• Rubella Antibodies Test Reagents

  Class II

  FDA 510(k) K810309 Active Cleared 11 Mar 1981

• Fibro-Tec Test Kit

  Class II

  FDA 510(k) K791358 Active Cleared 4 Sep 1979

• Rapi/Tex Aso Standard Serum

  Class I

  FDA 510(k) K800642 Active Cleared 24 Apr 1980

• Rheumatoid Factors Reference Serum

  Class II

  FDA 510(k) K810404 Active Cleared 11 Mar 1981

• Enzygnost Tm Rubella Igm

  Class II

  FDA 510(k) K813493 Active Cleared 4 Mar 1982

See all devices from Calbiochem-Behring Corp. →

• What is the Creatine Kinase-MB Kit used for?

  The Creatine Kinase-MB Kit is designed for measuring creatine phosphokinase-MB (CK-MB) isoenzyme levels in clinical chemistry laboratories. CK-MB is a cardiac-specific biomarker used to diagnose and monitor myocardial infarction (heart attack) and other cardiac conditions. The kit employs a quantitative colorimetric assay to distinguish CK-MB from other creatine kinase isoforms, helping clinicians assess cardiac injury with greater precision.

• How is the Creatine Kinase-MB Kit supplied and prepared?

  The kit is supplied as a single-use diagnostic device, intended exclusively for laboratory use by trained personnel. It is not sterile and requires manual handling and preparation according to the manufacturer’s instructions. The kit is not pre-assembled or pre-sterilized, so proper laboratory practices must be followed during setup and testing to ensure accurate results.

• Is the Creatine Kinase-MB Kit reusable or single-use?

  The kit is explicitly designed for single-use only. This ensures consistency in assay performance and minimizes the risk of cross-contamination or degradation of reagents between tests. Reusing the kit could compromise diagnostic accuracy and is not recommended by the manufacturer.

• What storage conditions should be followed for the Creatine Kinase-MB Kit?

  While specific storage conditions and shelf life are not detailed in the regulatory data, adherence to standard laboratory practices is implied for optimal performance. This typically includes storing the kit in a clean, dry environment protected from extreme temperatures, direct sunlight, and contamination. Always refer to the manufacturer’s instructions for precise storage guidelines.

• What regulatory pathway does the Creatine Kinase-MB Kit follow?

  The kit is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K820812. It is classified as a Class II medical device (product code JHY) and falls under the Clinical Chemistry advisory committee. The device was determined to be substantially equivalent to a predicate device, allowing it to enter the market with this regulatory pathway.