# K230161: ONLINE TDM Phenytoin - Free Phenytoin application

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Mar 30, 2023 after 69 days
- Product code: MOJ (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free))
- 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
Longest line of descent: 1 generation back to K952555 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952555: Cobas-FP Application for Free Phenytoin, Cobas-FP Phenytoin Calibrators, & Controls, Roche Diagnostic Systems, Inc. (1995) Summary page 4.

## Indications for use
ONLINE TDM Phenytoin - Free Phenytoin application is an in vitro test for the quantitative determination of free phenytoin in human serum and plasma on cobas c systems. The determination of free phenytoin is used in monitoring levels of free phenytoin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K230161
Methodology: https://510kreport.com/methodology