# K032089: Roche Diagnostics Elecsys Precicontrol Cardiac

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 30, 2003 after 23 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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.
41 later devices descend from it; 2 cite it directly.
0 of 47 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) Summary page 1.

## Most influential descendants
- K072437: Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset (2008), 20 descendants of its own
- K033937: Elecsys Precicontrol Multianalyte (2004), 19 descendants of its own
- K102157: Elecsys Precicontrol Multimarker (2010), 9 descendants of its own
- K082699: Elecsys Troponin I and Troponin I Stat Test Systems (2009), 9 descendants of its own
- K162895: Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 (2017), 8 descendants of its own

## Indications for use
PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Digoxin, Myoglobin, and NT-proBNP immunoassays on the Elecsys immunoassay systems.

Source page: https://510kreport.com/device/K032089
Methodology: https://510kreport.com/methodology