Search Results

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

2. Sample Sizes Used for the Test Set and Data Provenance

• Linearity Standards:
  • Manual procedure: Data from "linearity standards" (number not explicitly stated, but regression done with df = 23, suggesting 24 data points or more).
  • SYNCHRON CX® Systems: 6 linearity standards were used.
• Precision Studies:
  • Manual procedure: 30 replicates for each of 2 serum controls and 2 urine pools.
  • SYNCHRON CX® Systems: 60 replicates for each of 3 serum controls and 2 urine pools.
  • Sensitivity determination: 30 replicates of a diluted serum control.
• Comparison to Predicate Device:
  • Manual procedure: 95 mixed serum and plasma specimens, and 44 urine specimens.
  • SYNCHRON CX® Systems: 153 mixed serum and plasma specimens.
• Chemical Additives: Spiked and unspiked serum pools (number not specified).
• Calibration/Reagent Stability (SYNCHRON CX® Systems): Serum controls and urine pools were assayed over claimed periods (number of samples/pools not specified).

Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, such studies for in vitro diagnostics are typically conducted in a laboratory setting under controlled conditions. The studies are prospective in the sense that they are specifically designed to test the performance of the new reagent.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a chemical reagent, and the "ground truth" for phosphorus concentration is established by the reference method (predicate device, or the actual concentration of spiked standards), not by expert consensus or interpretation.

4. Adjudication Method for the Test Set

Not applicable. The comparisons are quantitative measurements against either known standards or a legally marketed predicate device, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an in vitro diagnostic reagent, not an AI-powered diagnostic imaging or interpretation tool. There are no human readers involved in the "interpretation" of the phosphorus concentration in the same way there would be for an AI-assisted diagnostic.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence, the entire study is "standalone" performance. The HiChem Phosphorus Reagent, once integrated with a spectrophotometer or clinical analyzer, performs its function (quantifying phosphorus) without human intervention in the measurement process itself. The performance data presented (linearity, precision, correlation to predicate) is the standalone performance of the reagent.

7. The Type of Ground Truth Used

The ground truth for this device is established by:

• Known concentrations: For linearity standards and sensitivity studies, the ground truth is the known, pre-determined concentration of phosphorus in the prepared standards.
• Reference method/device: For comparison studies, the "ground truth" (or reference) is the measurements obtained from the legally marketed predicate devices (BMD® Phosphorus Reagent on the Hitachi® 704 and Beckman® SYNCHRON® Systems Phosphorus Reagent on the SYNCHRON CX® Systems). The comparison aims to show substantial equivalence to these established methods.

8. The Sample Size for the Training Set

Not applicable. This is a chemical reagent and does not involve AI/Machine Learning models that require training sets in the computational sense. The "training" in developing such a reagent would be chemical formulation and optimization, not data-driven model training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of AI/ML for this device.

Ask a specific question about this device