# K992900: Precinorm Universal and Precipath Universal Control Sera

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 24, 1999 after 86 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: 1 generation back to K811832 (1981). 1 ancestor in all.
18 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811832: Precinorm U & Precipath U Human Serum, Boehringer Mannheim Corp. (1981) Summary page 1.

## Most influential descendants
- K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera (2004), 17 descendants of its own
- K122083: Elitech Clinical Systems CK Nac SL (2012), 1 descendant of its own
- K153644: ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II (2016), 0 descendants of its own
- K151552: ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II (2015), 0 descendants of its own
- K141265: Elitech Clinical Systems Envoy 500 CK Reagent Kit (2014), 0 descendants of its own

## Indications for use
For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs. The control is used for monitoring accuracy or precision both for manual techniques and assays from Roche on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K992900
Methodology: https://510kreport.com/methodology