# K060318: Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Aug 8, 2006 after 181 days
- Product code: CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot)
- Device class: 2
- Regulation: 21 CFR 862.1100
- 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: 1 generation back to K801118 (1980). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801118: Cobas Reagent for Ast (Sgot), Roche Analytical Instruments, Inc. (1980) Summary page 2.

## Most influential descendants
- K102647: Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1 SL/Potassium, Sodium, Chloride... (2011), 0 descendants of its own
- K093883: Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250, Assl-0455, Cali-0580, Cont-0080, Cont- (2010), 0 descendants of its own

## Recalls of this device
- Oct 10, 2012 · Class II · Z-0632-2013: 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
Hepatic Enzymes reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes. ABX PENTRA AST CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of aspartate aminotransferase in human serum and plasma based on a UV test using L-aspartate and 2-oxoglutarate. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers. The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision. The ABX PENIRA P Control is for use in quality control by monitoring accuracy and precision.

Source page: https://510kreport.com/device/K060318
Methodology: https://510kreport.com/methodology