Creatine Kinase MB Enzyme Immunoassay Kit

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

510(k) Number

K884550 ↗

FDA Product Code

JHY

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Creatine Kinase MB Enzyme Immunoassay Kit used for?

  This kit measures creatine kinase MB isoenzyme (CK-MB) levels using a colorimetric immunoassay method. CK-MB is a cardiac-specific biomarker, so it helps diagnose and monitor myocardial infarction (heart attack) and other cardiac conditions by providing quantitative results in clinical chemistry labs.

• How is the kit supplied and intended for use?

  The kit is supplied as a reagent kit designed exclusively for single-use in laboratory settings. It is not intended for reuse or direct patient contact, and it requires proper storage as outlined in the accompanying instructions.

• Is sterility a requirement for this device?

  No, sterility is not applicable for this device. It is classified as a non-sterile reagent kit, meaning it does not undergo sterilization processes and is not intended for sterile procedures.

• What regulatory clearance does this kit hold?

  The kit holds FDA 510(k) clearance under the reference number K884550. This clearance indicates it is classified as substantially equivalent to a predicate device and adheres to regulation 862.1215 for colorimetric methods used in clinical chemistry.

• Can this kit be used in MRI environments?

  No MRI safety information is provided for this kit. Since it is a reagent kit and not a medical device intended for use in MRI environments, it should not be assumed to be MRI-compatible without explicit manufacturer guidance.