# K123983: Fastpack Vitamin D; Immunoassay, Calibrators, Controls, Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Qualigen, Inc.
- Decided: Jul 3, 2013 after 189 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
Longest line of descent: 3 generations back to K032844 (2004). 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)
- K112725: Liaison 25 OH Vitamin D Total Assay, DiaSorin, Inc. (2012) Summary page 4.

## Recalls of this device
- Jul 7, 2017 · Class II · Z-3112-2017: Specific lots have been reported to produce falsely lower than expected results for Vitamin D
- Nov 8, 2013 · Class II · Z-0550-2014: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

## Indications for use
FastPack® Vitamin D Immunoassay is intended for the quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The FastPack® Vitamin D Immunoassay is intended for use with the FastPack® Analyzer. FastPack® Vitamin D Calibrator Kit is used for calibrating the quantitative FastPack® Vitamin D Immunoassay on the FastPack® Analyzer. FastPack® Vitamin D Control Kit is used for quality control of the FastPack® Vitamin D Immunoassay on the FastPack® Analyzer. FastPack® Vitamin D Method Verification Kit is used in the quantitative verification of calibration and assay range of the quantitative FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.

Source page: https://510kreport.com/device/K123983
Methodology: https://510kreport.com/methodology