# K034055: Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin I

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Jan 21, 2004 after 22 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: 2 generations back to K004002 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022118: Immulite Turbo CK-MB, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests), Diagnostic Products Corp. (2002) Summary page 2.
- K991796: Immulite Turbo Myoglobin, Models LSKMY1, LSKMY5, Diagnostic Products Corp. (1999) Summary page 4.
- K991795: Immulite Turbo Troponin I, Models LSKTI1, LSKTI5, Diagnostic Products Corp. (1999) Summary page 6.

## Recalls of this device
- Jan 25, 2012 · Not classified · Z-1274-2012: 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 2500 CK-MB is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction. The IMMULITE 2500 Myoglobin is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI). The IMMULITE 2500 STAT Troponin I is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

Source page: https://510kreport.com/device/K034055
Methodology: https://510kreport.com/methodology