CK-NAC Reagent (Creatine Kinase/N-Acetyl Cysteine)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K864359 ↗

FDA Product Code

CGS

FDA applicant

Trace Scientific , Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Trace Scientific, Ltd. →

• What is the CK-NAC reagent used for?

  The CK-NAC reagent is used to measure creatine kinase activity through NAD reduction and NADH oxidation in clinical chemistry testing. It helps assess enzyme levels as part of diagnostic evaluations in laboratory settings.

• How is the CK-NAC reagent supplied and cleared for use?

  The reagent is supplied as a traditional 510(k) cleared in vitro diagnostic product under FDA regulation number 862.1215 with product code CGS. It received substantial equivalence determination based on its similarity to legally marketed devices.

• Is the CK-NAC reagent sterile, single-use, or reusable?

  The provided data does not indicate whether the CK-NAC reagent is sterile, single-use, or reusable. No specifications regarding sterility, use classification, or reprocessing are included in the device information.