# K113177: Complete D 25-OH Vitamin D Control

- Pathway: 510(k) (Traditional)
- Applicant: Quantimetrix Corp.
- Decided: May 10, 2012 after 195 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K891475 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110641: Fujirebio Diagnostics Vitamin D Control, Fujirebio Diagnostics,Inc. (2011) Summary page 1.

## Indications for use
The Quantimetrix Complete D®D 25-OH Vitamin D Control is intended for the quality control of laboratory procedures used to quantitate Total 25-OH Vitamin D.

Source page: https://510kreport.com/device/K113177
Methodology: https://510kreport.com/methodology