# K991277: Modification to Immulite Myoglobin, Model LKMY1, LKMY5

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Apr 27, 1999 after 13 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
Longest line of descent: 1 generation back to K974325 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974325: Chiron Diagnostics Acs:180 Myoglobin, Chiron Diagnostics Corp. (1997) Summary page 1.

## Indications for use
IMMULITE® 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 and 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/K991277
Methodology: https://510kreport.com/methodology