(469 days)
Proteins 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 Albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry.
Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
ABX PENTRA Total Protein CP reagent, with associated calibrators 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.
ABX PENTRA Micro-albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Albumin in urine (µALB) at low concentration by immunoturbidimetric assay.
Measurements of albumin aids in the diagnosis of diabetic nephritis and other kidney and intestinal diseases.
The ABX PENTRA µ-Alb Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Micro-albumin CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA u-Alb Control L/H is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA Micro-albumin CP method.
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 Albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum and plasma based on a colorimetric test using Bromocresol Green (BCG). It is composed of a 99 ml mono-reagent cassette.
The ABX PENTRA Total Protein 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 61 ml mono-reagent cassette.
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 Micro-albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human urine based on an immunoturbidimetric test. It is composed of a bi-reagent cassette, with 19 ml and 4.5 ml compartments.
The ABX PENTRA u-Alb Cal is a liquid calibrator prepared by adding purified human albumin to a chemical buffer solution. It has 5 levels to be used for the calibration of the urinary albumin assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA u-Alb Control L/H is a liguid assayed control prepared by adding purified human albumin to a chemical buffer solution. It has 2 levels (Low and High) to be used for the quality control of the urinary albumin assay. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 1 ml.
The provided text describes performance data for a set of reagents, controls, and calibrators used with the ABX PENTRA 400 clinical chemistry analyzer. The studies conducted are in vitro diagnostic assay performance evaluations, not studies involving human readers or clinical outcomes in the same way an AI-powered diagnostic device would be evaluated. As such, several requested items (MRMC study, expert ground truth, adjudication methods) are not applicable to this type of submission.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The provided tables summarize the performance characteristics. The document states that "The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices." While specific numeric acceptance criteria for each metric (e.g., "CV Total must be
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.