# K123171: Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont

- Pathway: 510(k) (Abbreviated)
- Applicant: Horiba Abx Sas
- Decided: Jul 3, 2013 after 267 days
- Product code: CJY (Azo Dye, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- Recalls of this device: none
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061575: Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117, Olympus America, Inc. (2006) 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
- K151113: ELITech Clinical Systems CALCIUM ARSENAZO (2015), 0 descendants of its own

## Indications for use
ABX Pentra Calcium AS CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on a colourimetric method, using the ABX Pentra 400 Clinical Chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). 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 PENTRA N Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers. The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.

Source page: https://510kreport.com/device/K123171
Methodology: https://510kreport.com/methodology