(188 days)
ABX PENTRA Bilirubin, Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) for use on ABX PENTRA 400 Clinical Chemistry Analyzer.
ABX PENTRA Bilirubin, Total CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) and detergents for use on ABX PENTRA 400 Clinical Chemistry Analyzer.
Measurements of the levels of bilirubin (direct or total), an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
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 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).
All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters.
The provided text describes the performance data for the ABX PENTRA Bilirubin Reagents (Direct CP and Total CP), Calibrators, and Controls, but it does not specify explicit acceptance criteria. Instead, it presents observed performance metrics and concludes that these metrics "met all acceptance criteria." The study is a submission for a 510(k) premarket notification, indicating it is a validation study demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit acceptance criteria are not provided in the document, I will infer them from the reported performance data where applicable. The document states that "performance testing data conclude that... they met all acceptance criteria," implying that the reported values are within acceptable limits.
ABX PENTRA Bilirubin, Direct CP:
| Performance Metric | Reported Device Performance | Inferred Acceptance Criteria (based on reported performance) |
|---|---|---|
| Sample type | Serum & plasma | Use with Serum & plasma |
| Detection limit | 0.04 mg/dl | ≤ 0.04 mg/dl |
| Accuracy and Precision | CV Total |
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.