# K081276: Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Sep 12, 2008 after 130 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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 K971954 (1997). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944406: Olympus Glucose Reagent, Olympus America, Inc. (1995) Summary page 2.
- K971485: Uric Acid - Incorporating Dynamic Stabilization Technology - (DST), Trace America, Inc. (1997) Summary page 2.
- K070146: Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP, Horiba Abx (2007) Summary page 2.

## Most influential descendants
- K183375: Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode (2019), 0 descendants of its own
- K100263: Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents (2011), 0 descendants of its own

## Recalls of this device
- Jan 11, 2016 · Class II · Z-0743-2016: N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, an

## Indications for use
ABX PENTRA Glucose HK CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.. ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

Source page: https://510kreport.com/device/K081276
Methodology: https://510kreport.com/methodology