(121 days)
Creatinine and Total Protein reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.
ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
ABX PENTRA Total Protein 100 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
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.
The ABX PENTRA Urine Control L/H 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 Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA Total Protein 100 CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 28 ml mono-reagent cassette. Reagent is a chemical solution 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 Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels.
Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA Creatinine 120 CP and ABX PENTRA Total Protein 100 CP devices, based on the provided text:
Acceptance Criteria and Device Performance
The devices are in vitro diagnostic assays, and their performance is described in terms of analytical characteristics. The stated performance data implicitly serve as the acceptance criteria for the devices to be considered substantially equivalent to their predicate devices.
ABX PENTRA Creatinine 120 CP
| Acceptance Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sample type | Serum, Plasma and Urine compatibility | Serum, Plasma and Urine |
| Detection limit | Specified limits for serum/plasma and urine | Serum/Plasma: 0.18 mg/dl; Urine: 1.39 mg/dl |
| Accuracy and Precision | CV Total below specified percentages | Serum/Plasma CV Total |
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.