# K070146: Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Oct 12, 2007 after 269 days
- Product code: CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K971954 (1997). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971477: Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST), Trace America, Inc. (1997) Summary page 2.
- K070249: Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/H, Horiba Abx (2007). Cleared while this submission was under review Summary page 3.

## Most influential descendants
- K081276: Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H (2008), 2 descendants of its own
- 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

## Indications for use
ABX PENTRA Urea CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and glutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

Source page: https://510kreport.com/device/K070146
Methodology: https://510kreport.com/methodology