# K063145: Phenobarbital, Phenytoin, TDM Calibration Set B and Abtrol/Nortrol Controls

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Electron OY
- Decided: Oct 17, 2007 after 366 days
- Product code: DIP (Enzyme Immunoassay, Diphenylhydantoin)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CEDIA® Phenytoin II: named in the summary without a submission number

## Indications for use
Phenytoin is intended for quantitative in vitro diagnostic determination of the phenytoin concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy. TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981647 Phenytoin assay on T60 Analyzer.

Source page: https://510kreport.com/device/K063145
Methodology: https://510kreport.com/methodology