# K991796: Immulite Turbo Myoglobin, Models LSKMY1, LSKMY5

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Jun 9, 1999 after 14 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- Recalls of this device: none
- 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

## Indications for use
IMMULITE® Turbo Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of myoglobin in serum or heparinized 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/K991796
Methodology: https://510kreport.com/methodology