# K110619: Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D Controls

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: Nov 23, 2011 after 265 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: 2 generations back to K032844 (2004). 2 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071480: Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602, DiaSorin, Inc. (2007) Summary page 1.

## Most influential descendants
- K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5 (2012), 8 descendants of its own
- K162840: Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (2017), 4 descendants of its own
- K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3 (2013), 2 descendants of its own
- K210901: Elecsys Vitamin D total III (2021), 1 descendant of its own
- K252431: Elecsys Calcitonin (2026), 0 descendants of its own

## Recalls of this device
- Dec 12, 2012 · Class II · Z-0698-2013: The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.

## Indications for use
Reagents The ARCHITECT 25-OH Vitamin 0 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin 0 (215-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is.to be used as an aid in the assessment of vitamin D sufficiency. Calibrators The ARCHITECT 25-OH Vitamin 0 Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of 25-hydroxyvitamin 0 (25-OH Vitamin 0) in human serum and plasma. Controls The ARCHITECT 25-OH Vitamin D Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System. when used for the quantitative determination of 25-hydroxyvitamin 0 (25-OH Vitamin 0) in human serum and plasma.

Source page: https://510kreport.com/device/K110619
Methodology: https://510kreport.com/methodology