# K040264: Calibrator for Automated Systems Proteins in Urine/CSF

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 2, 2004 after 58 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K001126: Peace of Mind Multiple Drugs of Abuse Test, Alatex Scientific, Inc. (2000). Our reading of the summary gave K001126, FDA’s number for Peace of Mind Multiple Drugs of Abuse Test (Alatex Scientific, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Roche Diagnostic Calibrator for Automated Systems (C.f.a.s.) Proteins”. Kept off the family tree.

## 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
C.f.a.s. (Calibrator for automated systems) PUC (Proteins in Urine/CSF) 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/K040264
Methodology: https://510kreport.com/methodology