# K071779: Abx Pentra Urine Cal

- Pathway: 510(k) (Abbreviated)
- Applicant: Horiba Abx
- Decided: Mar 5, 2008 after 247 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: 5 generations back to K871027 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050026: Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc, Roche Diagnostics (2005) Summary page 1.

## Indications for use
The ABX PENTRA Urine Cal is a calibrator for use in the calibration of the quantitative method: ABX PENTRA Urinary Proteins CP on Horiba ABX PENTRA 400 clinical chemistry analyzer.

Source page: https://510kreport.com/device/K071779
Methodology: https://510kreport.com/methodology