Ames TDA Phenytoin Test
by Miles Laboratories, Inc. 510(k)
Active
510(k) K811025
Overview
The Ames TDA Phenytoin Test is a fluorescent immunoassay designed for the qualitative detection of phenytoin (diphenylhydantoin) in biological specimens. As a diagnostic tool, it aids in clinical toxicology assessments by identifying the presence of phenytoin, a medication used to treat epilepsy and other seizure disorders. This test supports patient monitoring for therapeutic drug levels or potential toxicity, ensuring safe and effective pharmacotherapy management.
This device is supplied as a single-use immunoassay kit and is intended for use in clinical laboratory settings. It operates under standard laboratory conditions without requiring MRI compatibility or specialized storage beyond its manufacturer-recommended parameters. The test follows regulatory standards under FDA 510(k) clearance (K811025), classified under device code LES and regulation 862.3350, ensuring compliance with clinical toxicology diagnostic requirements. No additional sterilization or reprocessing is required, as it is designed for one-time use per test.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811025 | Date29 Apr 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Ames Tda Tm Phenytoin Test
- 510(k) Number
- FDA Product Code
- LES
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3350
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Miles Laboratories, Inc.
Questions
What is the Ames TDA Phenytoin Test used for?
The Ames TDA Phenytoin Test is designed for the qualitative detection of phenytoin (diphenylhydantoin) in biological specimens. It serves as a diagnostic tool in clinical toxicology to identify the presence of phenytoin, a medication used to manage epilepsy and seizure disorders. This helps clinicians monitor therapeutic drug levels or assess potential toxicity, ensuring safe and effective pharmacotherapy management for patients.
How is the Ames TDA Phenytoin Test supplied and intended for use?
The test is supplied as a single-use immunoassay kit, meaning each kit is intended for one test only and cannot be reused or reprocessed. It is specifically intended for use in clinical laboratory settings under standard laboratory conditions. No additional sterilization or specialized storage is required beyond the manufacturer’s recommended parameters.
Is the Ames TDA Phenytoin Test sterile, and how should it be stored?
The Ames TDA Phenytoin Test is designed for single-use and does not require sterilization or reprocessing. Storage should follow the manufacturer’s guidelines, which are typically outlined in the accompanying documentation. Proper storage ensures the integrity and reliability of the test results, as it is sensitive to environmental conditions like temperature and humidity.
What regulatory pathway does the Ames TDA Phenytoin Test follow?
The Ames TDA Phenytoin Test follows the FDA 510(k) clearance pathway, specifically under clearance number K811025. It is classified under device code LES and regulation 862.3350, ensuring compliance with clinical toxicology diagnostic requirements. The device was determined to be substantially equivalent to a predicate device by the FDA, with a decision date of April 29, 1981.
Does this test require specialized equipment or conditions beyond standard laboratory settings?
No, the Ames TDA Phenytoin Test does not require specialized equipment like MRI compatibility or unique storage conditions beyond what is recommended by the manufacturer. It is designed to operate under standard laboratory conditions, making it accessible for routine use in clinical toxicology assessments.