# K983693: Dimensions (R) RXL Cardiac 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 K973668 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973668: Cardiac Troponin-I (Trop) Calibrator, Dade Intl., Inc. (1997) Summary page 1.

## Indications for use
The Cardiac Troponin-I (TROP) Calibrator is intended to be used to calibrate the Cardiac Troponin-I Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Source page: https://510kreport.com/device/K983693
Methodology: https://510kreport.com/methodology