(158 days)
CRP reagent, with associated calibrators and controls, are intended for use on ABX PENIRA 400 ClinicaLChemistry Analyzer to measure C-reactive Protein analyte.
The ABX PENTRA CRP Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CRP CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA Low CRP Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CRP CP method.
ABX PENTRA CRP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the C-reactive protein in human serum and plasma based on an immunoturbidimetric assay.
The ABX PENTRA Immuno I Control L/H is for use in quality control by monitoring accuracy and precision for CRP.
Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.
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 CRP CP is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum and plasma based on an immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 25 ml and 23.5 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA CRP Cal is a liquid human serum calibrator with chemical additives. It has 5 levels to be used for the calibration of the crp assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA Immuno I Control L/H is a lyophilized two-level quality control product consisting of human serum. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each level of control is provided in one vials of 3 ml.
The ABX PENTRA Low CRP Control is a liquid assayed control prepared by diluting crp at low concentration in human serum. It has to be used for the quality control of low levels measured with the crp assay. The assigned value is given in the enclosed annex. This control is provided in four vials of 1 ml.
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. They are respectively provided in mono-reagent 30 ml and 4 x 99 ml cassettes.
The provided document describes the Horiba ABX PENTRA CRP CP reagent and associated calibrators, controls, and cleaning solutions for use on the ABX PENTRA 400 clinical chemistry analyzer. The study detailed is aimed at demonstrating substantial equivalence to predicate devices for these in vitro diagnostic products.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a distinct set of pre-defined thresholds. Instead, it presents "Performance Data" for the reagents, which are implicitly considered in evaluating substantial equivalence. For the purpose of this response, I will interpret the 'Performance Data' section for the ABX PENTRA CRP CP reagent as the established performance and thus the implicit criteria met by the device.
| Performance Characteristic | Acceptance Criteria (Implicit from Reported Performance) | Reported Device Performance (ABX PENTRA CRP CP) |
|---|---|---|
| Sample Type | Serum & plasma compatibility | Serum & plasma |
| Detection Limit | Ability to detect CRP at low concentrations | 0.09 mg/l |
| Accuracy and Precision | CV Total within acceptable clinical limits | Conventional range: CV Total |
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).