# K072536: Esa Biosciences Inc. Vitamin D HPLC Test

- Pathway: 510(k) (Traditional)
- Applicant: Esa Biosciences, Inc.
- Decided: May 7, 2008 after 243 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: 1 generation back to K032844 (2004). 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)
- K032844: Liaison 25 OH Vitamin D, DiaSorin, Inc. (2004) Summary page 1.

## Indications for use
The ESA Biosciences Inc. Vitamin D HPLC test is for the quantitative determination of 25-hydroxyvitamin D in human serum or EDTA-plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions in an adult population.

Source page: https://510kreport.com/device/K072536
Methodology: https://510kreport.com/methodology