# K973414: Ace Phenytoin Reagent, Aed Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Schiapparelli Biosystems, Inc.
- Decided: Nov 4, 1997 after 56 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
Longest line of descent: 1 generation back to K945725 (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)
- K945725: Phenytion Eia Test, Diagnostic Reagents, Inc. (1995) Summary page 1.

## Indications for use
ACE® Phenytoin Reagent is intended for the quantitative determination of phenytoin in serum using the ACE® clinical chemistry analyzer. Phenytoin is one of the most widely prescribed anti-convulsant drugs for the treatment of epilepsy, particulary grand mal epilepsy (major motor), corticol focal seizures and temporal lobe epilepsy.

Source page: https://510kreport.com/device/K973414
Methodology: https://510kreport.com/methodology