# K962575: Elecsys Precicontrol Cardiac

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 22, 1996 after 21 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: 2 generations back to K931172 (1993). 3 ancestors in all.
52 later devices descend from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961501: Elecsys CK-MB, Boehringer Mannheim Corp. (1996) Summary page 1.
- K961500: Elecsys Troponin T, Boehringer Mannheim Corp. (1996) Summary page 1.

## Most influential descendants
- K983492: Boehringer Mannheim Elecsys Presicontrol Cardiac (1998), 51 descendants of its own
- K032089: Roche Diagnostics Elecsys Precicontrol Cardiac (2003), 41 descendants of its own
- 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

## Indications for use
Control for Elecsys® CK-MB and Troponin-T assays.

Source page: https://510kreport.com/device/K962575
Methodology: https://510kreport.com/methodology