(130 days)
ABX PENTRA Glucose HK CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of uric acid in human serum, plasma and urine 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.
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 bench top clinical chemistry analyzer.
The ABX PENTRA Glucose HK CP is an in vitro diagnostic assay for the quantitative determination of glucose in human serum, plasma and urine based on an enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase. It is composed of a bi-reagent cassette, with 56 ml and 14 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Uric Acid CP is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). It is composed of a bi-reagent cassette, with 60 ml and 15 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 annex, 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.
Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA Glucose HK CP and ABX PENTRA Uric Acid CP, focusing on the added urine sample performance. The ABX PENTRA Urine Control L/H is simply a control for these assays and its performance is described in terms of stability, not analytical performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (ABX PENTRA Glucose HK CP - Urine) | Reported Device Performance (ABX PENTRA Uric Acid CP - Urine) |
|---|---|---|---|
| Limit of Blank | Not explicitly stated | 1.95 mg/dl | 2.33 mg/dl |
| Limit of Detection | Not explicitly stated | 2.9 mg/dl | 3.49 mg/dl |
| Limit of Quantitation | Not explicitly stated | 3.3 mg/dl | 5.20 mg/dl |
| Accuracy and Precision | CV Total 0.99 (Implied, from context of "correlation coefficient") | r² = 0.997 (Y = 0.96 x + 0.84 mg/dl) | r² = 0.9949 (Y = 1.01 x + 0.99 mg/dl) |
| Calibration stability | Not explicitly stated | 21 days | 15 days |
| Reagent stability (closed) | Not explicitly stated | 36 months at 2-8°C | 36 months at 2-8°C |
| Reagent stability (on-board) | Not explicitly stated | 55 days (refrigerated area) | 41 days (refrigerated area) |
Note: The document states that the performance testing data demonstrated that the devices "met all acceptance criteria." However, explicit numerical acceptance criteria are not provided for all metrics. The reported performance values themselves serve as the demonstration of meeting internal acceptance criteria. For correlation, an R² value of >0.99 is generally considered excellent in such studies, hence the implied criterion. For CV Total, often
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.