# K090541: Elecsys Precicontrol Universal

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jul 2, 2009 after 122 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: 7 generations back to K931172 (1993). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051687: Elecsys Precicontrol Universal, Roche Diagnostics Corp. (2005) Summary page 2.

## Most influential descendants
- K130469: Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control Thyroid 3 (2013), 0 descendants of its own

## Indications for use
Elecsys PreciControl Universal is used for quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K090541
Methodology: https://510kreport.com/methodology