# K030428: Roche Online TDM Phenytoin

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 28, 2003 after 77 days
- Product code: DIP (Enzyme Immunoassay, Diphenylhydantoin)
- Device class: 2
- Regulation: 21 CFR 862.3350
- 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: 2 generations back to K905689 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963840: Cedia Phenytoin II Assay, Boehringer Mannheim Corp. (1996) Summary page 1.

## Recalls of this device
- Jun 18, 2004 · Not classified · Z-1062-04: May report falsely decreased patient results.
- Jun 18, 2004 · Not classified · Z-1063-04: May report falsely decreased patient results.

## Indications for use
The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin, an anti-convulsant drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K030428
Methodology: https://510kreport.com/methodology