(148 days)
ABX PENTRA Cholesterol CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
ABX PENTRA HDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of High Density Lipoprotein Cholesterol (HDL-C) in human serum and plasma based on an enzymatic assay with accelerator selective detergent methodology.
ABX PENTRA LDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and plasma based on an enzymatic colorimetric assay.
ABX PENTRA Triglycerides CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of triglycerides in human serum and plasma based on an enzymatic colorimetric assay. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
The ABX PENTRA HDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HDL Direct CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA LDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA LDL Direct CP method on Horiba ABX clinical chemistry analyzers.
All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of their respective analytes : Cholesterol, HDL-C. LDL-C and Triglycerides using human serum and plasma. The controls, calibrators and additional reagents are intended for use in association with the above reagents.
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 Cholesterol CP is an in vitro diagnostic assay for the quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of High Density Lipoprotein Cholesterol (HDL-C) in human serum and plasma based on an enzymatic test, with accelerator selective detergent methodology. The assay is composed of a bi-reagent cassette, with 62 ml and 21 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and plasma based on an enzymatic colorimetric test. It is composed of a bi-reagent cassette, with 28 ml and 10 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Triglycerides CP is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA HDL Cal is a lyophilized calibrator prepared from human serum. It is used for the calibration of the HDL-C assay. The assigned value is given in the enclosed annex. This calibrator is provided in two vials of 1 ml.
The ABX PENTRA LDL Cal is a lyophilized calibrator prepared from human serum. It is used for the calibration of the LDL-C assay. The assigned value is given in the enclosed annex. This calibrator is provided in two vials of 1 ml.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.
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 assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 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.
This submission pertains to the Horiba ABX PENTRA line of reagents, calibrators, and controls for use with the ABX PENTRA 400 Clinical Chemistry Analyzer. The performance data discussed focuses on the quantitative determination of Cholesterol, HDL-C, LDL-C, and Triglycerides in human serum and plasma.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for each analyte are implicitly defined by the reported performance claims. The study demonstrates that the devices met these criteria.
ABX PENTRA Cholesterol CP:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sample Type | Serum & plasma |
| Detection Limit | 4 mg/dl |
| Accuracy and Precision | CV Total |
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.