(272 days)
Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.
ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test.
Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy.
The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods.
ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoqlobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay.
Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision.
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 CK NAC CP is an in vitro diagnostic assay for the quantitative determination of total creatine kinase in human serum and plasma based on an optimized UV 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 Myoglobin CP is an in vitro diagnostic assay for the quantitative determination of myoglobin in human serum and plasma based on a latex-enhanced immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 15 ml and 9.5 ml compartments. Reagents are chemical solutions with chemical additives and substances of animal origin.
The ABX PENTRA Myoglobin Cal is a liquid calibrator prepared from a dilution of purified myoglobin positive human sera. It is used for the calibration of the myoglobin assay. The assigned values are given on the vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA CK Control is a lyophilized assayed control prepared from a bovine serum albumin with chemical additives and material of biological origin. It has to be used for the quality control of the creatine kinase assay. The assigned values are given in the enclosed annex. This calibrator is provided in 4 vials of 3 ml.
The ABX PENTRA Immuno II Control L/H is a lyophilized assayed control prepared from a stabilized pool of human sera. It has 2 levels (Low and High) to be used for the quality control of the myoglobin assay. The assigned values are given in the enclosed annex. Each level of this control is provided in one vial of 3 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.
This submission describes various reagents, controls, and calibrators for in vitro diagnostic use with the Horiba ABX Pentra 400 clinical chemistry analyzer. The performance data focuses on establishing substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily performance characteristics of the various reagents, controls, and calibrators.
ABX PENTRA CK NAC CP (Reagent for Total Creatine Kinase)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 8 U/l |
| Accuracy and Precision | CV Total |
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.