Creatine Kinase (CK) Isoenzyme MB

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K881168 ↗

FDA Product Code

JHT

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Hemoglobin Controls

  Class II

  FDA 510(k) K790457 Active Cleared 4 Apr 1979

• Gamma Glutamyl Transferase Procedure

  Class I

  FDA 510(k) K863586 Active Cleared 3 Oct 1986

• Direct Bilirubin Procedure

  Class II

  FDA 510(k) K881166 Active Cleared 28 Apr 1988

• Data-Zyme Glucose Hexokinase UV

  Class II

  FDA 510(k) K801052 Active Cleared 23 May 1980

• Data-Zyme Triglyceride Procedure

  Class I

  FDA 510(k) K780379 Active Cleared 12 May 1978

• Magnesium Procedure

  Class I

  FDA 510(k) K861668 Active Cleared 27 May 1986

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• What is the primary clinical purpose of the Creatine Kinase (CK) Isoenzyme MB system, and how does it differ from general CK testing?

  The Creatine Kinase (CK) Isoenzyme MB system is specifically designed to measure and differentiate CK-MB levels in clinical samples. Unlike general CK testing, which measures total creatine kinase activity, this system identifies myocardial infarction (heart attack) by detecting cardiac muscle damage through CK-MB—a biomarker unique to heart tissue—using chromatographic separation to distinguish it from skeletal muscle injury.

• Is this device single-use, or can it be reused in a clinical chemistry lab setting?

  This device is not single-use. It is supplied as a reagent kit for chromatographic separation and must be handled according to standard laboratory protocols for reagent storage and sample processing. Reagents are intended for repeated use in compatible instrumentation, provided proper laboratory practices are followed.

• What regulatory pathways does this device follow, and how does that affect its use in clinical settings?

  The Creatine Kinase (CK) Isoenzyme MB system holds both FDA 510(k) clearance under classification II and compliance with the In Vitro Diagnostic Device Directive (IVDD). This means it has undergone regulatory review to ensure safety and performance for in vitro diagnostic use in clinical chemistry laboratories, allowing clinicians to rely on its accuracy for detecting CK-MB levels in patient samples.

• What type of instrumentation or consumables are required to operate this system, and how is it supplied?

  This system is supplied as a reagent kit specifically designed for use with compatible chromatographic instrumentation. The kit includes all necessary reagents for separation, but additional consumables (such as sample vials or electrophoresis media) may be required depending on the manufacturer’s specifications. Always refer to the manufacturer’s instructions for full compatibility and operational details.