# K033487: Stratus CS Acute Care Troponin I Testpak, Model Cctni

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 24, 2003 after 50 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
Longest line of descent: 2 generations back to K981098 (1998). 2 ancestors in all.
6 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)
- K984093: Stratus (R) CS Cardiac Troponin I (Trop) Testpak, Dade Behring, Inc. (1998) Summary page 1.
- K981098: Stratus CS Cardiac Troponin I Testpak, Dade Behring, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K130603: Pathfast CTNL Calibrators (2014), 0 descendants of its own

## Recalls of this device
- Apr 3, 2006 · Not classified · Z-0876-06: Foil sealing of the TestPak 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 fals

## Indications for use
The Stratus® CS Acute CareTM Troponin I method is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of myocardial infarction. Cardiac troponin I can also be used 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/K033487
Methodology: https://510kreport.com/methodology