# K110530: Abx Pentra Creatinine 120 CP; Abx Pentra Multical;  Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control

- Pathway: 510(k) (Abbreviated)
- Applicant: Horiba Abx Sas
- Decided: Apr 30, 2012 after 431 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 3 (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.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934361: Olympus Creatinine Reagent, Olympus Corp. (1993) 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.

## Most influential descendants
- K191396: Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (2019), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class II · Z-1586-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- Jan 20, 2014 · Class II · Z-1146-2014: HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creati
- Dec 18, 2013 · Class III · Z-0924-2014: HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PEN

## Indications for use
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 (Jaffd 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. The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical clinical chemistry analyzers. The ABX PENTRLA 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 L11I is for use in quality control by monitoring accuracy and precision.

Source page: https://510kreport.com/device/K110530
Methodology: https://510kreport.com/methodology