# K162754: FREND Vitamin D Test System

- Pathway: 510(k) (Traditional)
- Applicant: Nanoentek USA, Inc.
- Decided: Jan 12, 2017 after 104 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.
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)
- K110619: Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D Controls, Biokit, S.A. (2011) Summary page 8.

## Indications for use
The FREND™ Vitamin D test is a rapid indirect competitive fluorescent immunoassay designed for the quantitative measurement of 25-Hydroxy vitamin D and related hydroxylated metabolites in human serum and plasma (K;EDTA, lithium-heparin and citrate) specimens using the FREND™ System, and the FREND™ AP System. Measurements of total 25-hydroxy vitamin D and related hydroxylated metabolites are used to aid in the assessment of vitamin D sufficiency. The FREND™ Vitamin D microfluidic flow cartridge is designed for use in the FREND™ System fluorescent immunoassay reader, and the FREND™ AP System. The FREND™ Vitamin D Test System is intended for use in clinical laboratories. For in vitro diagnostic use only. The test is not intended for use in point-of-care settings.

Source page: https://510kreport.com/device/K162754
Methodology: https://510kreport.com/methodology