# K993026: Abbot Aeroset Phenytoin Assay & Abbot Aeroset Phenytoin Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jan 27, 2000 after 140 days
- Product code: DIP (Enzyme Immunoassay, Diphenylhydantoin)
- Device class: 2
- Regulation: 21 CFR 862.3350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913429 (1991). 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)
- K913429: Emit (R) 2000 Phenytoin Assay/Calibrators, Syva Co. (1991) Summary page 1.

## Recalls of this device
- Feb 15, 2008 · Not classified · Z-2059-2008: An Abbott investigation has determined that the phenytoin reagent does not maintain an onboard stability of 28 days as stated in the phenytoin package insert. In addition, the 14 day calibration inter

## Indications for use
The Abbott Aeroset® Phenytoin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenytoin in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenytoin concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anti-convulsant medication for the following reasons: « Serum phenytoin concentrations correlate better with pharmacologic activity than does dosage because of individual differences in absorption, metabolism, disease states, concomitant medication, and compliance. Serum concentration monitoring helps physicans individualize dosage regimens. o The hepatic enzyme system for metabolizing phenytoin can become saturated within the drug's therapeutic range. When this occurs, small dosage alterations can lead to unexpected drug accumulation and clinical toxicity. » Phenytoin is safe and effective only in a narrow range of serum concentrations. o Methods historically used to monitor serum phenytoin concentrations include ‘wat raphic assays and immunoassays.

Source page: https://510kreport.com/device/K993026
Methodology: https://510kreport.com/methodology