(41 days)
HiChem Phosphorus Reagent is intended for the quantitative determination of inorganic phosphorus in serum, plasma and urine for the diagnosis and treatment of various disorders including parathyroid gland and kidney diseases, and vitamin D imbalance.
The HiChem Phosphorus Reagent determines phosphorus by its reaction with molybdate in an acidic solution to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.
The HiChem Phosphorus Reagent is an adaptation of the method first described by Simonsen and is intended for use with manual spectrophotometers or clinical analyzers which can automate the required manipulations.
Here's a breakdown of the HiChem Phosphorus Reagent device's acceptance criteria and the study information as detailed in the provided document:
This document describes a diagnostic reagent, not an AI/ML powered device, therefore some of the requested information (like MRMC studies, number of experts for ground truth, adjudication methods) is not applicable. I will provide the information that is applicable based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Manual Procedure) | Reported Device Performance (Manual Procedure) | Acceptance Criteria (SYNCHRON CX® Systems) | Reported Device Performance (SYNCHRON CX® Systems) |
|---|---|---|---|---|
| Linearity Range | 0.1 - 15 mgP/dL | 0.1 - 15 mgP/dL (Linear) | 1.0 - 12.0 mgP/dL | At least 1.0 - 12.0 mgP/dL (Linear) |
| r² (Correlation) | Implied high correlation | 1.000 (Manual) | Implied high correlation | 1.000 (SYNCHRON CX®) |
| Sensitivity | 0.1 mgP/dL (Claimed) | 0.05 mgP/dL (Observed, 0.1 mgP/dL, but sensitivity claim is 1.0 mgP/dL. There seems to be a discrepancy in the original text where it states "well below the claimed limit of 0.1 mgP/dL" after stating the sensitivity claim is 1.0 mgP/dL. I will assume the 1.0 mgP/dL is the correct claim for the SYNCHRON CX® system and 0.3 mgP/dL is well below that.) | ||
| Precision (Within-run SD) | Implied low variation | 0.02 - 0.07 mgP/dL (Serum) | ||
| 0.00 - 0.06 mgP/dL (Urine) | Implied low variation | 0.08 - 0.11 mgP/dL (Serum) | ||
| 0.08 - 0.11 mgP/dL (Urine) | ||||
| Precision (Total SD) | Implied low variation | 0.03 - 0.08 mgP/dL (Serum) | ||
| 0.00 - 0.07 mgP/dL (Urine) | Implied low variation | 0.09 - 0.13 mgP/dL (Serum) | ||
| 0.11 - 0.13 mgP/dL (Urine) | ||||
| Comparison to Predicate (r²) | Implied high correlation to predicate | 0.985 (Serum/Plasma), 0.999 (Urine) | Implied high correlation to predicate | 0.972 (Serum/Plasma), 0.996 (Urine) |
| Chemical Additive Bias |
§ 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.