EMIT AED Carbamazepine Assay
by Syva Co. 510(k)
Active
510(k) K832720
Overview
The EMIT AED Carbamazepine Assay is an enzyme immunoassay for carbamazepine. It is classified under product code KLT and device class II with special controls.
The assay was cleared via FDA 510(k) pathway under K832720, with a decision date of October 4, 1983. It is manufactured by Syva Co. and intended for use in clinical toxicology settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832720 | Date4 Oct 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- Withdrawn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
- KLT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3645
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the EMIT AED Carbamazepine Assay used for?
The EMIT AED Carbamazepine Assay is an enzyme immunoassay designed to detect carbamazepine levels in clinical samples, intended for use in clinical toxicology settings to support therapeutic drug monitoring and overdose assessment.
How is the EMIT AED Carbamazepine Assay supplied and is it single-use?
The assay is supplied as a reagent kit for enzyme immunoassay testing; while the data does not explicitly state single-use or reusable format, enzyme immunoassays like this are typically designed for single-use per test run to prevent cross-contamination and ensure accurate results in clinical laboratories.
What regulatory pathway was used for the EMIT AED Carbamazepine Assay clearance?
The EMIT AED Carbamazepine Assay was cleared via the FDA 510(k) pathway under submission K832720, with a decision of substantial equivalence granted on October 4, 1983, based on its classification under product code KLT and device class II with special controls.