# K012233: Stratus CS Troponin I Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 11, 2001 after 57 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: 2 generations back to K981100 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K983722: Stratus CS Troponin I Calibrator, Dade Behring, Inc. (1998) Summary page 1.

## Most influential descendants
- 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 (¢Tnl CalPak) is an in vitro diagnostic product intended to be used for calibration of the cardiac troponin [ method on the Stratus® CS analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of troponin I values.

Source page: https://510kreport.com/device/K012233
Methodology: https://510kreport.com/methodology