# K983722: Stratus CS Troponin I Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 4, 1998 after 14 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K981100 (1998). 1 ancestor in all.
2 later devices descend from it; 2 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)
- K981100: Stratus CS Trop Calpak, Dade Behring, Inc. (1998) Summary page 1.

## Most influential descendants
- K012233: Stratus CS Troponin I Calibrator (2001), 1 descendant of its own
- K051650: Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute Care CKMB Testpak. (2005), 0 descendants of its own

## Indications for use
The Cardiac Troponin-I Calibrator (TROP CalPak) is intended to be used to calibrate the Cardiac Troponin I method on the Stratus® CS analyzer.

Source page: https://510kreport.com/device/K983722
Methodology: https://510kreport.com/methodology