# K180577: BioPlex 2200 25-OH Vitamin D Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Jun 22, 2018 after 109 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: 3 generations back to K021163 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Bio-Rad Laboratories (2015) Summary page 4.

## Indications for use
BioPlex 2200 25-OH Vitamin D Kit The BioPlex 2200 25-OH Vitamin D Kit is a multiplex 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.

Source page: https://510kreport.com/device/K180577
Methodology: https://510kreport.com/methodology