# K991177: Opus Troponin I (CTN) Test Modules

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 1, 1999 after 85 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Dimension® RxL Troponin I Flex™ Reagent Cartridge: named in the summary without a submission number

## Indications for use
The Troponin I (cTn) assay for the Opus™ Immunoassay System is a device used to measure cardiac troponin I in serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

Source page: https://510kreport.com/device/K991177
Methodology: https://510kreport.com/methodology