Advance EMIT-AED Ethosuximide
by Syva Co. 510(k)
Active
510(k) K823745
Overview
The Advance EMIT-AED Ethosuximide is an enzyme immunoassay (EIA) designed for the qualitative detection of ethosuximide in biological specimens. It falls under the category of clinical toxicology assays, enabling rapid screening for the presence of this anticonvulsant drug in patient samples.
This device is supplied as a diagnostic reagent kit for in vitro use, intended for laboratory settings. It is classified as a Class II medical device under FDA regulations (product code DLF) and was granted a 510(k) clearance in 1983. The assay is intended for single-use per manufacturer specifications, with no explicit mention of MRI safety or sterility requirements in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823745 | Date7 Jan 1983 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- DLF
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3380
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the Advance EMIT-AED Ethosuximide used for in a clinical setting?
The Advance EMIT-AED Ethosuximide is an enzyme immunoassay (EIA) designed specifically for the qualitative detection of ethosuximide in biological specimens, such as blood or urine. It serves as a rapid screening tool in clinical toxicology to identify the presence of this anticonvulsant drug in patient samples, helping clinicians assess potential drug exposure or overdose.
Is this device intended for single-use or can it be reused?
The Advance EMIT-AED Ethosuximide is explicitly labeled for single-use per manufacturer specifications. This means each kit is designed for one test cycle and should not be reused, as reuse could compromise accuracy or introduce contamination.
How is the Advance EMIT-AED Ethosuximide supplied, and where is it intended for use?
This device is supplied as a diagnostic reagent kit for in vitro use. It is intended exclusively for laboratory settings, where trained personnel can perform the enzyme immunoassay to detect ethosuximide in patient samples. The kit includes all necessary components for a single test.
What type of regulatory clearance does this device hold, and when was it approved?
The Advance EMIT-AED Ethosuximide received a 510(k) clearance from the FDA in January 1983 under the classification of a Class II medical device (product code DLF). This clearance was granted through a traditional review process, with the device deemed *substantially equivalent* to a predicate device in clinical toxicology assays.
Does the manufacturer specify any special handling or storage requirements for this kit?
While the provided data does not detail specific storage conditions, as a diagnostic reagent kit, it should be stored according to standard laboratory protocols for immunoassay reagents—typically in a cool, dry place, protected from light and extreme temperatures. Always follow the included instructions for optimal performance and shelf life.