# K031990: Elecsys Precicontrol Troponin T

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 20, 2003 after 54 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: 4 generations back to K931172 (1993). 5 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983492: Boehringer Mannheim Elecsys Presicontrol Cardiac, Boehringer Mannheim Corp. (1998)

## Most influential descendants
- K060585: Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth (2006), 4 descendants of its own
- K092322: Elecsys Rubella Igm Immunoassay (2010), 2 descendants of its own
- K142133: Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV Igm (2014), 1 descendant of its own
- K111335: ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321 (2011), 1 descendant of its own
- K223867: Ids Acth II (2023), 0 descendants of its own

## Indications for use
PreciControl Troponin T is used for quality control of the Elecsys Troponin T (CARDIAC T) immunoassay of the Elecsys immunoassay systems.

Source page: https://510kreport.com/device/K031990
Methodology: https://510kreport.com/methodology