# K050026: Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Jan 31, 2005 after 25 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871027 (1987). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040264: Calibrator for Automated Systems Proteins in Urine/CSF, Roche Diagnostics Corp. (2004) Summary page 2.
- K041812: Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath Proteins in Urine/CSF (Puc), Roche Diagnostics Corp. (2004) Summary page 3.

## Most influential descendants
- 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. C.fa.s. PUC is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Source page: https://510kreport.com/device/K050026
Methodology: https://510kreport.com/methodology