(76 days)
The IDS Gamma-B 1,25-Dihydroxy Vitamin D kit is a complete assay system intended for the purification of 1,25-dihydroxyvitamin D (1,25D) in human serum or plasma by immunoextraction followed by quantitation by 1251 radioimmunoassay. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in,the assessment of 1,25D deficiency associated with renal disease in adult populations. For In Vitro Diagnostic Use Only.
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This is an FDA Premarket Notification (510(k)) letter for the device "Gamma-B 1, 25-Dihydroxy Vitamin D." This document is a clearance letter and does not contain the detailed study results or acceptance criteria that would typically be found in a submission document or a medical publication.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be stated based on the document:
1. A table of acceptance criteria and the reported device performance:
- Cannot be determined from this document. This document is a clearance letter, not a detailed study report. It states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device met the necessary performance criteria submitted in the original 510(k) application, but these specific criteria and the reported performance are not present in this letter.
2. Sample size used for the test set and the data provenance:
- Cannot be determined from this document. The document does not provide details about sample sizes or the origin of the data used for the substantial equivalence determination.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be determined from this document. This information is not part of the FDA clearance letter.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be determined from this document. Adjudication methods are typically detailed in study protocols, which are not included here.
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. The device described is an "in vitro diagnostic" (IVD) test system (specifically, a radioimmunoassay for 1,25-dihydroxyvitamin D). It is not an AI-assisted diagnostic imaging device, so MRMC studies and human reader improvement with AI are not relevant for this type of product.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an AI algorithm. This is an IVD kit, which provides a quantitative result. Its performance is evaluated through analytical and clinical studies, not typically as a "standalone algorithm" in the way an AI medical imaging algorithm would be. The device itself is the "standalone" indicator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be determined from this document. For an IVD, ground truth would typically refer to a reference method or clinical diagnosis based on established criteria and other laboratory and clinical data. However, the specific method used for this device's validation is not described here. The indications for use state "Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of 1,25D deficiency associated with renal disease in adult populations." This implies that the ground truth would be a clinical diagnosis informed by multiple data points.
8. The sample size for the training set:
- Not applicable / Cannot be determined. This device is an immunoassay kit, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its development involves optimization and validation using various samples, but not a distinct "training set" for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable. As above, the concept of a "training set" ground truth isn't directly relevant to this type of IVD device.
In summary, this document is an FDA clearance letter confirming substantial equivalence to a predicate device. It does not provide the detailed scientific study information requested as part of the 510(k) application.
§ 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.