(65 days)
The IDS 1,25-Dihydroxy Vitamin D EIA 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 enzymeimmunoassay. 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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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device. It does not contain information about acceptance criteria, device performance, study details (like sample size, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment for either training or test sets. Therefore, I cannot generate the requested table and study description from this input.
The document primarily focuses on:
- Granting substantial equivalence for the "1, 25-Dihydroxy Vitamin D EIA" device.
- Listing the regulation number, name, and product code.
- Stating the intended use of the device: "to assist the clinician in the assessment of 1,25D deficiency associated with renal disease in adult populations" in conjunction with other clinical and laboratory data.
- Providing information about regulatory requirements and contacts.
§ 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.