(90 days)
ABX PENTRA Calcium CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
ABX PENTRA Creatinine CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic 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 Phosphorus CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
ABX PENTRA Amylase CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum, plasma and urine based on an enzymatic photometric assay. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
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 Calcium CP is an in vitro diagnostic assay for the quantitative determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. It is composed of a bi-reagent cassette, with 66 ml and 16.5 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Creatinine 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 bi-reagent cassette, with two 28 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Phosphorus CP is an in vitro diagnostic assay for the quantitative determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. It is composed of a mono-reagent cassette, with 29.5 ml compartment. The reagent is a chemical solution with additives.
The ABX PENTRA Amylase CP is an in vitro diagnostic assay for the quantitative determination of alpha-amylase in human serum, plasma and urine based on an enzymatic photometric 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 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 annexe, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
The provided text describes the performance data for new urine sample indications for four reagents (ABX PENTRA Calcium CP, ABX PENTRA Creatinine CP, ABX PENTRA Phosphorus CP, and ABX PENTRA Amylase CP) when used with the ABX PENTRA 400 Clinical Chemistry Analyzer. The study aims to demonstrate substantial equivalence to predicate devices and establish performance characteristics for urine samples.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are implied by the reported performance characteristics for each reagent on urine samples. While explicit "acceptance criteria" are not listed as pass/fail thresholds, the reported values represent the achieved performance that allowed for the 510(k) clearance.
ABX PENTRA Calcium CP (Urine)
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sample type | Urine | Urine |
| Detection limit | Not explicitly defined | 0.12 mg/dl |
| Accuracy and Precision | Not explicitly defined | CV Total |
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.