# K062180: Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CP

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Oct 2, 2006 after 63 days
- Product code: JFJ (Catalytic Methods, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801295: Cobas Reagent for a-Amylase, Roche Analytical Instruments, Inc. (1980) Summary page 2.
- K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module), Horiba Abx (2005) Summary page 1.

## Indications for use
Amylase reagent, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure amylase analyte. ABX PENTRA Amylase CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum and plasma based on an enzymatic photometric assay. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). 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 PENTRA P Control is for use in quality control by monitoring accuracy and precision.

Source page: https://510kreport.com/device/K062180
Methodology: https://510kreport.com/methodology