Modifica- of Emit Aed Ethosuximide Assay
by Syva Co. 510(k)
Active
510(k) K832797
Overview
This device is an Enzyme Immunoassay for the quantitative measurement of ethosuximide in biological specimens, classified under product code DLF. It is designed to detect and quantify ethosuximide levels, aiding in the clinical assessment of patients undergoing anticonvulsant therapy.
The Modifica-EMIT AED Ethosuximide Assay is intended for in vitro diagnostic use in clinical toxicology settings. Supplied as a single-use reagent kit, it requires no sterilisation beyond manufacturer-provided packaging. The device was granted FDA 510(k) clearance under Traditional review, with a decision date of September 29, 1983, and is classified as a Class II device under Special Controls. No additional regulatory status beyond the stated clearance is implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832797 | Date29 Sep 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- Withdrawn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 clinical setting is this assay primarily used in, and why is it relevant for monitoring patients?
This assay is designed for use in clinical toxicology settings, where it helps quantify ethosuximide levels in biological specimens. It aids clinicians in assessing patient compliance and therapeutic drug levels during anticonvulsant therapy, ensuring safe and effective treatment for epilepsy or related conditions.
Is this device single-use, and if so, how does that impact its handling and storage?
Yes, the Modifica-EMIT AED Ethosuximide Assay is supplied as a single-use reagent kit. This means each kit is intended for one use only, reducing the risk of contamination or cross-reactivity. Proper storage in the manufacturer-provided packaging—protected from extreme temperatures and light—is critical to maintaining assay integrity until use.
What type of biological specimens can this assay measure, and how does that affect its clinical utility?
While the device description specifies it is for *quantitative measurement of ethosuximide in biological specimens*, the exact specimen types (e.g., serum, plasma, urine) are not detailed here. Typically, such assays are used with serum or plasma for monitoring drug levels in blood. Clinicians rely on this to adjust dosages or verify patient adherence to anticonvulsant regimens, ensuring therapeutic efficacy while minimizing toxicity.
How is the regulatory clearance of this device relevant to its use in healthcare facilities?
The Modifica-EMIT AED Ethosuximide Assay received FDA 510(k) clearance under Traditional review in 1983, classified as a Class II device with Special Controls for clinical toxicology applications. This clearance indicates the device meets established safety and performance standards for its intended use in measuring ethosuximide levels. Facilities can trust its compliance with FDA requirements, though they should always follow manufacturer instructions and local guidelines for implementation.