# K984093: Stratus (R) CS Cardiac Troponin I (Trop) Testpak

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 14, 1998 after 28 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
Longest line of descent: 1 generation back to K981098 (1998). 1 ancestor in all.
7 later devices descend from it; 2 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)
- K981098: Stratus CS Cardiac Troponin I Testpak, Dade Behring, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K253051: i-STAT hs-TnI cartridge with the i-STAT Alinity System (2026), 0 descendants of its own

## 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/K984093
Methodology: https://510kreport.com/methodology