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Creatine Phosphokinase (CK) Procedure

by Data Medical Associates, Inc. 510(k)

Active United States

510(k) K863587

Overview

This device is a Nad Reduction/Nadh Oxidation, CPK or Isoenzymes procedure, classified under Clinical Chemistry. It measures creatine phosphokinase (CK) levels in blood or serum to aid in the diagnosis and monitoring of conditions such as myocardial infarction, muscular dystrophy, and other muscle or heart disorders. The procedure relies on enzymatic reactions to quantify CK activity, providing quantitative results for clinical interpretation.

The procedure is supplied as a reagent kit for in vitro diagnostic use in clinical laboratories. It is intended for single-use and requires proper storage at controlled temperatures to maintain stability. The device is regulated under FDA 510(k) clearance (K863587) and falls under the Class II medical device classification (product code: CGS). No MRI safety or sterility specifications are noted in the data, and regulatory compliance is confirmed through the submitted 510(k) submission to the FDA.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863587 Date3 Oct 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CGS
Device Class
Class II
Regulation
21 CFR Part 862.1215
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What clinical conditions is this creatine phosphokinase (CK) procedure designed to help diagnose or monitor?

    This procedure measures CK levels in blood or serum to aid in diagnosing and monitoring conditions like myocardial infarction (heart attacks), muscular dystrophy, and other muscle or heart disorders. The enzymatic reaction quantifies CK activity, providing measurable results for clinical interpretation.

  • How is this CK procedure supplied, and is it intended for single-use?

    The procedure is supplied as a reagent kit for in vitro diagnostic use in clinical laboratories. It is explicitly intended for single-use only, meaning each kit should not be reused after opening or initial use.

  • What storage conditions are required to maintain the stability of this CK procedure kit?

    The kit requires proper storage at controlled temperatures to maintain stability. While exact temperature ranges aren’t specified in the data, adherence to manufacturer guidelines (likely refrigeration or room temperature) is critical to preserve reagent efficacy.

  • What regulatory pathway was followed for this device, and what classification does it hold?

    This device was cleared through the FDA’s 510(k) pathway (traditional review) under clearance number K863587, with a decision of *substantially equivalent* to a predicate. It is classified as a Class II medical device under product code CGS, regulated under 21 CFR 862.1215 for Clinical Chemistry procedures.