(64 days)
The ATAC PAK Phosphorus Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
The ATAC PAK Phosphorus Reagent determines phosphorus through its reaction with molybdate to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.
Here's a breakdown of the acceptance criteria and the study details for the ATAC PAK Phosphorus Reagent Kit, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity Range | N/A (demonstrated over usable range) | 0.1 to 15 mg/dL |
| Linearity Regression (Slope) | Close to 1.00 | 0.991 |
| Linearity Regression (Intercept) | Close to 0 | -0.05 mg/dL |
| Linearity Regression (Correlation Coefficient, r) | Close to 1.000 | 1.000 |
| Linearity Regression (Standard Error of Y, SYX) | N/A | 0.11 mg/dL |
| Precision (Within-Run %CV) | N/A (compared to predicate or industry standard, generally low) | Serum 1: 3.2% |
| Precision (Total %CV) | N/A (compared to predicate or industry standard, generally low) | Serum 1: 5.0% |
| Method Comparison (Deming Regression Slope) | Close to 1.00 | 1.001 |
| Method Comparison (Deming Regression Intercept) | Close to 0 | -0.17 mg/dL |
| Method Comparison (Standard Error of Regression, Syx) | N/A | 0.17 mg/dL |
| Detection Limit | N/A (should be clinically acceptable for phosphorus) | 0.1 mg/dL |
| Onboard Reagent Stability | Total imprecision |
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.