# K042519: Gamma-B 1,25-Dihydroxy Vitamin D

- Pathway: 510(k) (Abbreviated)
- Applicant: Immunodiagnostic Systems, Ltd.
- Decided: Dec 1, 2004 after 76 days
- Product code: MRG (System, Test, Vitamin D)
- Device class: 2
- Regulation: 21 CFR 862.1825
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K042519
Methodology: https://510kreport.com/methodology