(95 days)
The IDS Gamma-B 25-Hydroxy Vitamin D kit is a liquid phase radioimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. For In Vitro Diagnostic Use Only.
liquid phase radioimmunoassay
The provided document is a 510(k) clearance letter from the FDA for a diagnostic device. It outlines the regulatory approval for the Gamma-B 25-Hydroxy Vitamin D RIA Kit and states its intended use. However, it does not contain the details of a study that proves the device meets specific acceptance criteria in the way a modern clinical trial or performance study report would.
The letter confirms the device is substantially equivalent to legally marketed predicate devices, which is a regulatory standard for market entry in the US for certain medical devices. This substantial equivalence is typically based on comparing the new device's technological characteristics and performance data to that of a predicate device.
Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document, as it focuses on regulatory approval rather than a detailed scientific study report.
Here's a breakdown of what can be inferred or what is missing:
1. A table of acceptance criteria and the reported device performance
- Missing from document: This document does not present a table of acceptance criteria or detailed performance data. The FDA's 510(k) clearance process would have reviewed such data, but it's not included in this letter. Performance claims like accuracy, precision, linearity, etc., would typically be in the 510(k) submission itself, not the clearance letter.
2. Sample size used for the test set and the data provenance
- Missing from document: The document does not specify the sample size used for any test set or the provenance of the data (e.g., country of origin, retrospective/prospective). Such information would be part of the performance study submitted to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Missing from document: Not applicable for an in vitro diagnostic device like this RIA kit, which measures quantitative levels of a biomarker. "Ground truth" for such devices typically comes from reference methods or established analytical techniques, not expert consensus on images or clinical assessments.
4. Adjudication method for the test set
- Missing from document: Not applicable for an in vitro diagnostic device. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving physician interpretation, for example, in imaging diagnostics.
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
- Missing from document: Not applicable. This device is a radioimmunoassay kit, not an AI-powered diagnostic tool requiring human interpretation improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing from document: Not applicable. This is not an algorithm, but a laboratory test kit. Its performance is evaluated biochemically.
7. The type of ground truth used
- Inferred: For an in vitro diagnostic assay like this, the "ground truth" for evaluating performance would likely involve established reference methods for 25-hydroxy vitamin D quantification (e.g., LC-MS/MS or other validated assays) or certified reference materials, rather than expert consensus, pathology, or outcomes data. This document doesn't explicitly state the ground truth method.
8. The sample size for the training set
- Missing from document: Not applicable typically for this type of RIA kit. While there's method development and optimization (which might involve a "training" phase in a general sense), there isn't a "training set" in the machine learning context for which a specific sample size would be reported in the performance evaluation.
9. How the ground truth for the training set was established
- Missing from document: See point 8. This concept doesn't directly apply here.
§ 862.1825 Vitamin D test system.
(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.