# K022118: Immulite Turbo CK-MB, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests)

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Jul 22, 2002 after 21 days
- Product code: JHX (Fluorometric Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K004002 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K004002: Immulite CK-MB, Model LKMB1 (100 Tests), LKMB5 (500 Tests); Immulite 2000 CK-MB, Model L2KMB2 (200 Tests), L2KMB6 (600), Diagnostic Products Corp. (2001) Summary page 2.

## Most influential descendants
- K034055: Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin I (2004), 0 descendants of its own

## Recalls of this device
- Jan 25, 2012 · Not classified · Z-1272-2012: Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). Th

## Indications for use
The IMMULITE Turbo CK-MB is for in vitro diagnostic use with the IMMULITE Analyzer - for the quantitative measurement of creatine kinase isoenzyme MEB (CK-MB) in serum or heparinized plasma, as an aid in patient management and the assessment of prognosis of myocardial infarction.

Source page: https://510kreport.com/device/K022118
Methodology: https://510kreport.com/methodology