# K963143: Elecsys Calcheck Troponin T

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Aug 23, 1996 after 10 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K924862 (1992). 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)
- K924862: Aia-Pack HCG Calibration Verification Test Set, Tosoh Medics, Inc. (1992) Summary page 1.

## Indications for use
Elecsys CalCheck Troponin T is intended for use in the quantitative verification of the calibration curve established by the Elecsys Troponin T reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.

Source page: https://510kreport.com/device/K963143
Methodology: https://510kreport.com/methodology