Ames Tda Phenytoin Test
by Miles Laboratories, Inc. 510(k)
Active
510(k) K801736
Overview
The Ames Tda Phenytoin Test is a fluorescent immunoassay used for the quantitative determination of diphenylhydantoin in clinical specimens. This device is classified as a clinical toxicology test designed to measure phenytoin levels.
This device is regulated under FDA 510(k) clearance K801736. It is intended for use in a clinical setting as part of a traditional premarket notification process.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801736 | Date20 Aug 1980 | 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- Withdrawn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 primary purpose of the Ames Tda Phenytoin Test?
This device is a clinical toxicology test used for the quantitative determination of diphenylhydantoin, also known as phenytoin, in clinical specimens. It is designed to provide precise measurements of drug levels within a clinical setting.
What is the regulatory status of this device?
The Ames Tda Phenytoin Test is regulated under FDA 510(k) clearance number K801736. It was processed through a traditional premarket notification and determined to be substantially equivalent to existing devices in the clinical toxicology category.
How is this test classified for clinical use?
The device is classified as a Class 2 fluorescent immunoassay under regulation number 862.3350. It falls under the clinical toxicology medical specialty, which governs the testing of specimens to measure specific drug concentrations.