# K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: May 27, 2004 after 17 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 K811832 (1981). 2 ancestors in all.
17 later devices descend from it; 16 cite 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)
- K992900: Precinorm Universal and Precipath Universal Control Sera, Roche Diagnostics Corp. (1999) Summary page 2.

## Most influential descendants
- 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
- K132399: Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine Control BI-Level (2014), 0 descendants of its own

## Indications for use
Precinorm U is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath U is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

Source page: https://510kreport.com/device/K041227
Methodology: https://510kreport.com/methodology