# K955562: Innofluor Phenytoin Assay System

- Pathway: 510(k) (Traditional)
- Applicant: Oxis Intl., Inc.
- Decided: Jan 24, 1996 after 49 days
- Product code: LGR (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total))
- Device class: 2
- Regulation: 21 CFR 862.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051211: QMS Zonisamide Reagents, Calibrators and Controls (2005), 3 descendants of its own
- K062966: QMS Lamotrigine Assay (Reagents), Calibrators & Controls (2007), 1 descendant of its own
- K101305: Ark Lamotrigine Assay, Calibrator & Control (2010), 0 descendants of its own
- K091884: Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro, Models 5022-0001-00, 5022-0002-00, 5022-0003 (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K955562
Methodology: https://510kreport.com/methodology