# K221817: ALFIS Vitamin D, ALFIS-3 Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Immunostics Inc.,
- Decided: Sep 22, 2023 after 457 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: 10 generations back to K931172 (1993). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210901: Elecsys Vitamin D total III, Roche Diagnostics (2021) Summary page 5.

## Indications for use
ALFIS Vitamin D in conjunction with ALFIS-3 Analyzer is an enzyme-linked fluorescence immunoassay intended for in vitro diagnostic use at clinical laboratories for the quantitative measurement of Total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum, lithium heparin plasma and sodium heparin plasma. ALFIS Vitamin D is indicated to be used as an aid in the determination of Vitamin D sufficiency in adults. ALFIS-3 Analyzer is a fluorescence-scanning instrument using magnetic beads and alkaline phosphatase enzyme system for in vitro diagnostic use in conjunction with various ALFIS immunoassays intended for measuring the concentration of designated analytes in human blood and other specimens.

Source page: https://510kreport.com/device/K221817
Methodology: https://510kreport.com/methodology