# K992148: Hydragel-Mini Iso-CK Kit, Hydragel Iso-CK Kit, Hydragel 7 IS0-CK Kit, Hydragel Iso-CK 15/30 Kit

- Pathway: 510(k) (Traditional)
- Applicant: Morax
- Decided: Dec 29, 1999 after 188 days
- Product code: CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
All Sebia’s Hydragel ISO-CK kits are intended for the identification and quantitation of the three creatine kinase (CK) isoenzymes, MM, MB and BB, by electrophoresis on alkaline buffered agarose gels followed by a densitometry. The creatine kinase (CK) isoenzyme, CK-MB, is primarily released from a damaged heart muscle. It is one of the earliest markers for distinguishing patients with acute mwocardial infarction o(AMI) from those with other coronary syndromes and episodes with similar symptoms. Biochemical assays have been, and remain so, the most reliable means of detecting myocardial injury. However, no single biochemical marker can alone give a complete picture of myocardial injury and its extent. Therefore, the assay of CK isoenzymes is often used in tandem with the assay of LD :soenzymes which are released slower from the injured heart muscle and remain. longer in circulation, to confirm or rule out the diagnosis of MI, assess its severity and monitor patient’s condition. The principles of HYDRAGEL ISO-CK assays are: the electrophoretic separation of the CK isoenzymes, the use of a specific chromogenic substrate for the CK catalyzed visualization reaction, and densitometric quantitation of the electrophoregrams.

Source page: https://510kreport.com/device/K992148
Methodology: https://510kreport.com/methodology