(63 days)
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.
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA Amylase CP is an in vitro diagnostic assay for the quantitative determination of alpha-amylase in human serum and plasma based on an enzymatic photometric test. The assay is composed of a bi-reagent cassette, with 26 ml and 6,5 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels.
The ABX PENTRA Clean-Chem CP and ABX PENTRA Clean-Chem 99 CP are ready-to-use chemical cleaning solutions for use on the ABX Pentra 400 system.
Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA Amylase CP and its associated calibrators and controls, based on the provided 510(k) summary:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| ABX PENTRA Amylase CP | ||
| Sample Type | N/A (indicates acceptable sample types) | Serum & plasma |
| Detection Limit | N/A | 4 U/l |
| Accuracy and Precision | CV Total |
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.