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EMIT Carbamazepine Assay

by Syva Co. 510(k)

Active United States

510(k) K780466

Overview

The EMIT Carbamazepine Assay is an enzyme immunoassay designed for the quantitative detection of carbamazepine in biological samples. It leverages enzyme-multiplied immunoassay technique (EMIT) to measure drug concentrations, aiding in clinical toxicology assessments and therapeutic drug monitoring.

This assay is supplied as a reagent kit for in vitro diagnostic use and is intended for single-use only. It requires no special storage conditions beyond refrigeration and is classified under FDA 510(k) clearance (K780466) as a Class II device under product code KLT. The device is regulated for clinical toxicology applications and adheres to standard laboratory safety protocols.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780466 Date24 Apr 1978ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

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

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Questions

  • What clinical applications is the EMIT Carbamazepine Assay primarily used for in a lab setting?

    The EMIT Carbamazepine Assay is designed for quantitative detection of carbamazepine in biological samples, making it essential for clinical toxicology assessments and therapeutic drug monitoring. This means it helps measure carbamazepine levels in patients to evaluate overdose risks, ensure proper dosing, or monitor compliance in treatment plans.

  • Is this assay intended for single-use or repeated testing, and what storage requirements apply?

    The EMIT Carbamazepine Assay is intended for single-use only per kit. It does not require specialized storage beyond standard refrigeration, ensuring stability for routine laboratory use without additional handling constraints.

  • How is the regulatory pathway for this device structured, and what does the product code (KLT) signify?

    The EMIT Carbamazepine Assay was cleared via an FDA 510(k) submission (K780466) under the Traditional review pathway, classified as a Class II device with product code KLT (Clinical Laboratory Tests). This classification reflects its role in diagnostic testing, specifically for clinical toxicology, rather than surgical or implantable applications.

  • Are there multiple versions or sizes of this assay, or is it supplied as a uniform kit?

    The data provided does not specify multiple versions or sizes; the EMIT Carbamazepine Assay is supplied as a single reagent kit for in vitro diagnostic use. The registration numbers listed (e.g., 3010939897) likely correspond to lot or batch tracking rather than distinct product variants.