# K021163: Octeia 25-Hydroxy Vitamin D

- Pathway: 510(k) (Traditional)
- Applicant: Immunodiagnostic Systems, Ltd.
- Decided: May 10, 2002 after 29 days
- Product code: MRG (System, Test, Vitamin D)
- Device class: 2
- Regulation: 21 CFR 862.1825
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 6 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110586: Advia Centaur Vitamin D Total Assay (2011), 3 descendants of its own
- K123660: 25-OH  Vitamin D Elisa (2013), 2 descendants of its own
- 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 (2015), 1 descendant of its own
- K133156: Advia Centaur Vitamin D Total (Vitd) Assay;Advia Centaur Vitd Total Calibrators,Quality Control & Master Control Materia (2014), 1 descendant of its own
- K200509: ADVIA Centaur Vitamin D Total (VitD) (2020), 0 descendants of its own

## Recalls of this device
- Nov 7, 2012 · Class II · Z-0697-2013: Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report was found to have an erroneous calibrator value assigned. The value of 24.4 ng/mL for calibrator 4 was
- Aug 2, 2008 · Not classified · Z-0173-2009: A small number of customers have experienced low absorbance values when using kits from this batch.

## Indications for use
The IDS OCTEIA® 25-Hydroxy Vitamin D kit is a enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency.

Source page: https://510kreport.com/device/K021163
Methodology: https://510kreport.com/methodology