# K991795: Immulite Turbo Troponin I, Models LSKTI1, LSKTI5

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Jun 9, 1999 after 14 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

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

## Recalls of this device
- Oct 27, 2014 · Class II · Z-0801-2015: 

## Indications for use
IMMULITE® Troponin I is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma. It is intended strictly for in vitro use as an aid in the diagnosis of acute myocardial infarction (AMI).

Source page: https://510kreport.com/device/K991795
Methodology: https://510kreport.com/methodology