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Creatine Kinase-MB

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162526

by Roche Diagnostics

Identifiers

510(k) Number
K162526 FDA 510(k)
FDA Product Code
JHW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1215 FDA 510(k)
Regulation Number
862.1215 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Creatine Kinase-MB (CK-MB) In Vitro Test is an immunoassay for the quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. It falls under the category of a U.V. Method and Cpk Isoenzymes, specifically designed for clinical chemistry applications. This test aids in assessing cardiac biomarkers to support diagnostic evaluations, particularly for myocardial infarction.

The device is supplied as a single-use reagent for use on cobas c, cobas e, or COBAS INTEGRA immunoassay analyzers. It is intended for in vitro diagnostic use only and requires no special sterility beyond standard laboratory handling. The test is regulated under FDA 510(k) clearance (K162526) and classified as a Class II medical device. Storage and handling follow standard laboratory protocols for immunoassay reagents.

Frequently asked questions

What clinical purpose does the Creatine Kinase-MB test serve in diagnosing patient conditions?

The Creatine Kinase-MB (CK-MB) test quantifies the MB isoenzyme of creatine kinase in human serum or plasma to help assess cardiac biomarkers. It is primarily used in clinical chemistry to support diagnostic evaluations for myocardial infarction (heart attack) by identifying elevated levels of CK-MB, which are indicative of cardiac muscle damage.

Which analyzers are compatible with this single-use reagent, and how is it supplied?

This test is designed for use exclusively on Roche Diagnostics’ cobas c, cobas e, or COBAS INTEGRA immunoassay analyzers. It is supplied as a single-use reagent, meaning each vial is intended for one test cycle and cannot be reused.

Does this test require special sterility precautions beyond standard laboratory handling?

No, the Creatine Kinase-MB test does not require additional sterility measures beyond those typically followed in a standard laboratory setting for immunoassay reagents. It is intended for in vitro diagnostic use only and adheres to routine handling protocols.

How is the device regulated, and what does its classification mean for clinical use?

The Creatine Kinase-MB test is regulated under the FDA’s 510(k) clearance pathway (K162526) and classified as a Class II medical device. This classification means it is subject to general controls and special controls to ensure its safety and effectiveness for quantitative measurement of CK-MB in serum/plasma, particularly for cardiac biomarker assessment.

What storage and handling guidelines should be followed for this reagent?

Storage and handling follow standard laboratory protocols for immunoassay reagents. Since it is a single-use reagent, it should be stored according to the manufacturer’s instructions (typically refrigerated or at room temperature, depending on the specific lot) and used within the indicated expiration date to maintain accuracy and reliability.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CKMB, Creatine Kinase-MB - Roche Diagnostics USA, CKMB, Creatine Kinase-MB - Roche Diagnostics USA, 07027087501V2.0 Elecsys CK-MB - Roche

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Diagnostics

Sources (1)

  • FDA 510(k) K162526 24 fields · synced Sep 19, 2026