# K012367: Vitamin D Test System Nichols Advantage 25-Hydroxyvitamin D

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Oct 9, 2001 after 75 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DiaSorin 25-Hydroxyvitamin D 25RIA kit: named in the summary without a submission number

## Recalls of this device
- Jun 30, 2004 · Not classified · Z-1118-04: Lower than expected results are obtained.

## Indications for use
The Nichols Advantage® 25-Hydroxyvitamin D assay is for use only on the Nichols Advantage® Specialty System. The Nichols Advantage 25-Hydroxyvitamin D assay is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used as an aid in the assessment of vitamin D sufficiency in an adult population. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

Source page: https://510kreport.com/device/K012367
Methodology: https://510kreport.com/methodology