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510(k) Data Aggregation
(431 days)
ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA
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.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical 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 reagent, controls and calibrator 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 in vitro determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a bi-reagent cassette (R1= 27.5 mL ; R2= 8 mL). Reagents are chemical solutions with additives.
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 SAS 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 SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
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. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
The provided text describes the acceptance criteria and performance data for the ABX PENTRA Creatinine 120 CP reagent and associated calibrators/controls, for use on the ABX PENTRA 400 clinical chemistry analyzer.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| ABX PENTRA Creatinine 120 CP (Reagent) | ||
| Detection limit (Serum/Plasma) | N/A (Comparison to predicate implies similar or better performance) | 0.074 mg/dl |
| Detection limit (Urine) | N/A | 1.40 mg/dl |
| Limit of Quantitation (Serum/Plasma) | N/A | 0.22 mg/dl |
| Limit of Quantitation (Urine) | N/A | 2.90 mg/dl |
| Accuracy and Precision (Serum/Plasma) | N/A (likely defined by an allowable CV% based on clinical standards or predicate) | CV. Total |
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(121 days)
ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
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 |
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