# K103788: Pentra C200, Ise Module and Abx Pentra Glucose HK CP Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx Sas
- Decided: Nov 8, 2011 after 316 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 K933930 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module), Horiba Abx (2005) Summary page 2.

## Recalls of this device
- Oct 10, 2012 · Class II · Z-0633-2013: Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AS

## Indications for use
The PENTRA C200 is a discrete photometric benchtop chemistry analyzer for use in clinical laboratories. It is not intended for use in Point of Care settings. It duplicates manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The PENTRA C200 is intended for quantitative measurements of a variety of analytes: Glucose, Sodium, Potassium and Chloride. ABX Pentra Glucose HK CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of glucose in serum and plasma 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 odiopathic hypoglycemnia, and of pancreatic islet cell carcinoma, The IS.E. (Ion Selective Electrode) Module is intended for the quantitative determination of Sodium, Potassium and Chloride in serum, plasma and urine by potentiomnetry using ion selective electrode with associated reference solution, calibrators and controls, Measurement of Sodium, Potassium and Chloride are used in diagnosis and treatment of diseases involving electrolyte imbalance.

Source page: https://510kreport.com/device/K103788
Methodology: https://510kreport.com/methodology