# K072115: Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and Urine Control L/H

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Nov 30, 2007 after 121 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933930 (1994). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973869: Trace Reagent Line for the Cobas Mira, Trace America, Inc. (1998) Summary page 2.
- K941837: Roche Reagent for Creatinine, Roche Diagnostic Systems, Inc. (1994) Summary page 2.
- K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module), Horiba Abx (2005) Summary page 1.
- K070249: Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/H, Horiba Abx (2007) Summary page 2.

## Recalls of this device
- Sep 14, 2012 · Class III · Z-0289-2013: This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using

## Indications for use
Creatinine and Total Protein reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes. ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. ABX PENTRA Total Protein 100 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers. The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision. The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

Source page: https://510kreport.com/device/K072115
Methodology: https://510kreport.com/methodology