Cobas Ready Ck Reagent

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

510(k) Number

K896240 ↗

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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See all devices from Roche Diagnostic Systems, Inc. →

• What is the COBAS READY CK REAGENT used for?

  The COBAS READY CK REAGENT is used for the quantitative determination of creatine kinase (CK) or its isoenzymes in human serum and plasma using a colorimetric method. It is intended for use in clinical chemistry laboratories on Roche/Hitachi cobas c systems as an in vitro diagnostic test to measure CK levels, which can help assess muscle or cardiac tissue damage.

• How is the COBAS READY CK REAGENT supplied and what systems is it compatible with?

  The reagent is supplied for use in clinical chemistry laboratories and is specifically designed for use on Roche/Hitachi cobas c systems. It is provided as a ready-to-use reagent formulation intended for quantitative creatine kinase testing on these automated platforms.

• Is the COBAS READY CK REAGENT a single-use or reusable reagent?

  The COBAS READY CK REAGENT is intended for single-use in diagnostic testing. As an in vitro diagnostic reagent for clinical chemistry, it is consumed during the assay process and not designed for reuse, ensuring consistent performance and preventing cross-contamination between patient samples.