# K973668: Cardiac Troponin-I (Trop) Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Oct 20, 1997 after 25 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Stratus® Cardiac Troponin-I Calibrators: named in the summary without a submission number

## Most influential descendants
- K983693: Dimensions (R) RXL Cardiac Troponin I Calibrator (1998), 0 descendants of its own

## Indications for use
The Cardiac Troponin-l Calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Source page: https://510kreport.com/device/K973668
Methodology: https://510kreport.com/methodology