# K142373: Access 25(OH) Vitamin  D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 22, 2014 after 119 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 K032844 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112725: Liaison 25 OH Vitamin D Total Assay, DiaSorin, Inc. (2012) Summary page 4.

## Most influential descendants
- K223503: Access 25(OH) Vitamin D Total (2023), 0 descendants of its own

## Indications for use
The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25‐hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the Access 2 Immunoassay Systems. Results are to be used as an aid in the assessment of vitamin D sufficiency. The Access 25(OH) Vitamin D Total Calibrators are intended to calibrate the Access 25(OH) Vitamin D Total assay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the Access 2 Immunoassay Systems.

Source page: https://510kreport.com/device/K142373
Methodology: https://510kreport.com/methodology