# K141114: Bioplex (R) 2200 25-OH Vitamin D Kit, Bioplex (R) 2200 25-OH Vitamin D Calibrator Set, and Bioplex (R) 2200 25-OH Vitamin D

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Jan 9, 2015 after 254 days
- Product code: MRG (System, Test, Vitamin D)
- Device class: 2
- Regulation: 21 CFR 862.1825
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021163 (2002). 2 ancestors in all.
1 later device descends 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)
- K123660: 25-OH  Vitamin D Elisa, Euroimmun US (2013) Summary page 6.

## Most influential descendants
- K180577: BioPlex 2200 25-OH Vitamin D Kit (2018), 0 descendants of its own

## Indications for use
The BioPlex® 2200 25-OH Vitamin D kit is a flow competitive immunoassay intended for the quantitative determination of 25-hydroxyvitamin D in human serum. The BioPlex 2200 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency. The BioPlex® 2200 25-OH Vitamin D kit is intended for use with the Bio-Rad BioPlex 2200 System. The BioPlex® 2200 25-OH Vitamin D Calibrator Set is intended for the calibration of the BioPlex® 2200 25-OH Vitamin D Reagent Pack. The BioPlex® 2200 25-OH Vitamin D Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex® 2200 System and the corresponding BioPlex® 25-OH Vitamin D Reagent Packs in the clinical laboratory. The performance of the BioPlex® 25-OH Vitamin D Control Set has not been established with any other 25-hydroxyvitamin D assays.

Source page: https://510kreport.com/device/K141114
Methodology: https://510kreport.com/methodology