# K042389: Modification to Precinorm Universal Plus and Precipath Universal Plus Control Sera

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 14, 2004 after 12 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.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993360: Precinorm Universal Plus and Precipath Universal Plus Control Sera, Roche Diagnostics Corp. (1999) Summary page 2.

## Most influential descendants
- K102016: Precicontrol Clinchem Multi 1 and 2 (2010), 1 descendant of its own
- K133330: C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein & Precipath Protein (2013), 0 descendants of its own
- K080485: Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FS (2008), 0 descendants of its own

## Indications for use
Precinorm ®U Plus is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath ® U Plus 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/K042389
Methodology: https://510kreport.com/methodology