ISOSCREEN-CK Confirmatory Kit

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

510(k) Number

K895870 ↗

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 ISOSCREEN-CK Confirmatory Kit used for?

  The ISOSCREEN-CK Confirmatory Kit is a colorimetric method device used for the quantitative determination of creatine kinase (CK) in human serum and plasma. It is designed specifically for use with Roche/Hitachi cobas c systems to measure CK levels or isoenzymes in clinical chemistry settings.

• How is the ISOSCREEN-CK Confirmatory Kit supplied?

  The kit is supplied as a Class 2 medical device manufactured by Roche Diagnostic Systems, Inc. It is intended for in vitro diagnostic use in clinical chemistry settings. The device is not specified as single-use or reusable, and no information regarding sterility or MRI safety is provided in the available documentation.

• What is the regulatory status of the ISOSCREEN-CK Confirmatory Kit?

  The ISOSCREEN-CK Confirmatory Kit is cleared by the FDA under 510(k) K895870 on December 1, 1989. It is classified as substantially equivalent and falls under the Clinical Chemistry advisory committee. The device is manufactured by Roche Diagnostic Systems, Inc. and is intended for in vitro diagnostic use in clinical chemistry settings.

• What systems is the ISOSCREEN-CK Confirmatory Kit compatible with?

  The ISOSCREEN-CK Confirmatory Kit is designed specifically for use with Roche/Hitachi cobas c systems. It is not compatible with other diagnostic systems unless explicitly stated in the product documentation. The kit is used to measure creatine kinase levels or isoenzymes in human serum and plasma samples.