(176 days)
General Chemistries 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 ALP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
ABX PENTRA Calcium CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of calcium in human serum and plasma 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 CO2 RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of carbon dioxide in human serum and plasma based on an enzymatic test using phosphoenolpyruvate (PEP), phosphorenolpyruvate carboxylase (PEPC) and an analog of NADH. Bicarbonate/carbon measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
ABX PENTRA Creatinine CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of creatinine in human serum and plasma 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 Iron CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of iron (non-heme) in human serum and plasma based on a photometric test (Ferene method). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and hemochromatosis.
ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of phosphorus in human serum and plasma based on a UV method using phosphomolybdate. Measurement 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 Urea CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of urea nitrogen (an end-product of nitrogen metabolism) in human serum and plasma based on an enzymatic UV test using urease and glutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of uric acid in human serum and plasma based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
The ABX PENTRA CO2 Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CO2 RTU method on Horiba ABX clinical chemistry analyzers as specified on the vial.
The ABX PENTRA CO₂ Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CO2 RTU method as specified in the enclosed annex.
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
Here's a breakdown of the acceptance criteria and study information for the Horiba ABX PENTRA reagents, controls, and calibrators, based on the provided 510(k) summary:
This submission is for multiple reagents, controls, and calibrators for the ABX PENTRA 400 clinical chemistry analyzer. The performance data is presented for each reagent individually. The acceptance criteria and reported performance will be summarized for each reagent as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the reported performance, which demonstrates that the devices "met all acceptance criteria" and are "substantially equivalent" to their respective predicate devices. Specific quantitative acceptance criteria are not explicitly stated as separate targets but are shown by the achieved performance values.
ABX PENTRA ALP CP (Alkaline phosphatase)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection limit met | 6 U/l |
| Accuracy and Precision met | CV Total |
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.