# K953567: Incstar 25-Hydroxyvitmin D 1251 Ria

- Pathway: 510(k) (Traditional)
- Applicant: Incstar Corp.
- Decided: Sep 25, 1996 after 422 days
- Product code: MRG (System, Test, Vitamin D)
- Device class: 2
- Regulation: 21 CFR 862.1825
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 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)
- None. The FDA summary names its predicate without a number.
- (no number) CPBA: named in the summary without a submission number
- (no number) HPLC: named in the summary without a submission number

## Most influential descendants
- K983617: 25-Hydroxyvitamin D 125I Ria Kit (1998), 2 descendants of its own
- 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
- Aug 21, 2007 · Not classified · Z-1237-2007: 25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.

## Indications for use
The INCSTAR 25-Hydroxyvitamin D 1251 RIA Kit is intended for the quantitative measurement of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency.

Source page: https://510kreport.com/device/K953567
Methodology: https://510kreport.com/methodology