# K983617: 25-Hydroxyvitamin D 125I Ria Kit

- Pathway: 510(k) (Special)
- Applicant: DiaSorin, Inc.
- Decided: Nov 16, 1998 after 32 days
- Product code: LCI (Automated Radioimmunoassay Systems, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953567 (1996). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953567: Incstar 25-Hydroxyvitmin D 1251 Ria, Incstar Corp. (1996). Our OCR of the scanned summary read K853567, FDA’s number for DJP Unipolar (Biotronik Sales, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “25-Hydroxyvitamin D ¹²⁵I RIA Kit”.

## Most influential descendants
- K123131: ST Aia-Pack 25-OH Vitamin D, ST Aia-Pack 25-OH Vitamin D Calibrator Set, Aia-Pack 25-OH Vitamin D Control Set, and ST AI (2013), 1 descendant of its own
- K150270: ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set (2015), 0 descendants of its own

## Recalls of this device
- Jun 30, 2004 · Not classified · Z-0705-05: An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18.

## Indications for use
FOR IN VITRO DIAGNOSTIC USE. This kit intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population.

Source page: https://510kreport.com/device/K983617
Methodology: https://510kreport.com/methodology