# K041812: Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath Proteins in Urine/CSF (Puc)

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 27, 2004 after 21 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: 3 generations back to K871027 (1987). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040280: Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls, Roche Diagnostics Corp. (2004) Summary page 2.

## Most influential descendants
- K050026: Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc (2005), 1 descendant of its own
- K071779: Abx Pentra Urine Cal (2008), 0 descendants of its own

## Indications for use
Precinorm ®PUC (Proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath ® PUC (Proteins in Urine/CSF) 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/K041812
Methodology: https://510kreport.com/methodology