# K991797: Immulite Turbo CK-MB, Models LSKCP1, LSKCP5

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Jun 9, 1999 after 14 days
- Product code: JHX (Fluorometric 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
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. The FDA summary names no predicate by number.

## Indications for use
IMMULITE® Turbo 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 serum or heparinized plasma. It is intended strictly for in vitro use as an aid in patient management and the assessment of prognosis of myocardial infarction.

Source page: https://510kreport.com/device/K991797
Methodology: https://510kreport.com/methodology