# K981495: Immulite CK-MB, Catalog # LKCP1 (100 Tests), LKCP5 (500 Tests)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jun 10, 1998 after 44 days
- Product code: JHS (Differential Rate Kinetic Method, 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
Longest line of descent: 1 generation back to K903025 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903025: Roche Isomune- CK, Roche Diagnostic Systems, Inc. (1990) Summary page 1.

## Indications for use
IMMULITE CK-MB is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) antigen in heparinized plasma or serum. It is intended strictly for i vitro use as an aid in patient management and the assessment of prognosis of myocardial infarction.

Source page: https://510kreport.com/device/K981495
Methodology: https://510kreport.com/methodology