# K040280: Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 11, 2004 after 34 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 K871027 (1987). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981401: Boehringer Mannheim Precinorm Precipath Protein Controls, Boehringer Mannheim Corp. (1998) Summary page 2.

## Most influential descendants
- K041812: Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath Proteins in Urine/CSF (Puc) (2004), 2 descendants of its own
- K050026: Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc (2005), 1 descendant of its own
- K132156: Randox CSF Controls Levels 2 and 3 (2013), 0 descendants of its own
- K071779: Abx Pentra Urine Cal (2008), 0 descendants of its own
- K062379: Cobas Integra Ceruloplasmin (2007), 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/K040280
Methodology: https://510kreport.com/methodology