# K993360: Precinorm Universal Plus and Precipath Universal Plus Control Sera

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 24, 1999 after 49 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.
4 later devices descend from it; 1 cites 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)
- K811832: Precinorm U & Precipath U Human Serum, Boehringer Mannheim Corp. (1981) Summary page 1.

## Most influential descendants
- K042389: Modification to Precinorm Universal Plus and Precipath Universal Plus Control Sera (2004), 3 descendants of its own
- 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
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/K993360
Methodology: https://510kreport.com/methodology