# K092570: Abx Pentra Tpu Cal, Model A11A01898

- Pathway: 510(k) (Abbreviated)
- Applicant: Horiba Abx Sas
- Decided: Oct 16, 2009 after 56 days
- Product code: JIT (Calibrator, Secondary)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ABX PENTRA Urine Cal: named in the summary without a submission number

## Most influential descendants
- K122177: Elitech Clinical Systems Urine Total Protein Plus Standard 100 MG/DL, Elitech Clinical Systems Urine Control BI-Level (2013), 0 descendants of its own

## 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 ABX PENTRA 400 clinical chemistry analyzer as specified on the vials.

Source page: https://510kreport.com/device/K092570
Methodology: https://510kreport.com/methodology