# K121608: Vitros Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack, Vitamin D Total Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Feb 15, 2013 after 259 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
Longest line of descent: 1 generation back to K091849 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091849: Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set, Immunodiagnostic Systems, Inc. (2010) Summary page 4.

## Recalls of this device
- Jan 15, 2014 · Class III · Z-1193-2014: Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin 

## Indications for use
VITROS* Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack: For in vitro diagnostic use only For the quantitative measurement of total 25-OH vitamin D in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. The results of the VITROS 25-OH Vitamin D Total assay are used in the assessment of Vitamin D sufficiency. Assay results may be used in conjunction with other clinical or laboratory data to assist the clinician in patient management. VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators: For in vitro diagnostic use only. For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH vitamin D in human serum.

Source page: https://510kreport.com/device/K121608
Methodology: https://510kreport.com/methodology