# K974325: Chiron Diagnostics Acs:180 Myoglobin

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Dec 8, 1997 after 20 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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 its predicate without a number.
- (no number) Stratus Myoglobin Fluorometric Enzyme Immunoassay: named in the summary without a submission number

## Most influential descendants
- K122599: Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin Calibrator (2012), 0 descendants of its own
- K991277: Modification to Immulite Myoglobin, Model LKMY1, LKMY5 (1999), 0 descendants of its own
- K983970: Immulite Myoglobin, Model LKMY1 and LKMY5 (1998), 0 descendants of its own

## Indications for use
The Chiron Diagnostics ACS:180 Myoglobin Assay is used for the quantitative determination of Myoglobin in serum or plasma and as an aid in the diagnosis of acute myocardial infarction using the Chiron Diagnostics ACS Automated Chemiluminescence Systems.

Source page: https://510kreport.com/device/K974325
Methodology: https://510kreport.com/methodology