# K981098: Stratus CS Cardiac Troponin I Testpak

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Apr 27, 1998 after 32 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.
8 later devices descend from it; 3 cite it directly.
0 of 9 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) Dade Stratus® analyzer: named in the summary without a submission number

## Most influential descendants
- K984093: Stratus (R) CS Cardiac Troponin I (Trop) Testpak (1998), 7 descendants of its own
- K033487: Stratus CS Acute Care Troponin I Testpak, Model Cctni (2003), 6 descendants of its own
- K100130: Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2 (2011), 4 descendants of its own
- K231974: PATHFAST®hs-cTnI-II (2024), 2 descendants of its own
- K240984: i-STAT hs-TnI cartridge with the i-STAT 1 System (2025), 1 descendant of its own

## Recalls of this device
- Apr 3, 2006 · Not classified · Z-0882-06: Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be false

## Indications for use
The TROP TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic product for the measurement of cardiac troponin I in heparinized plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

Source page: https://510kreport.com/device/K981098
Methodology: https://510kreport.com/methodology