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Cybrex Carbamazepine (K802902)

by Abbott Laboratories 510(k)

Active United States

510(k) K802902

Overview

The Cybrex Carbamazepine (K802902) is an enzyme immunoassay device designed for the qualitative detection of carbamazepine in biological specimens. It falls under the classification of enzyme immunoassays and is intended for use in clinical toxicology settings to identify the presence of carbamazepine, a medication used to treat epilepsy and bipolar disorder.

This device is supplied as a diagnostic test kit and is regulated under FDA 510(k) clearance with the product code KLT. It is intended for single-use in clinical laboratory settings and adheres to regulatory standards outlined in 862.3645. The device is not intended for MRI use and requires proper storage as per manufacturer guidelines to maintain accuracy and reliability.

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

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802902 Date19 Dec 1980ClearedStatusActive

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

1 recall · FDA

    • Terminated Z-0277-04 FDA Unclassified (pre-2012) initiated 17 Nov 2003

    The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges

Specification

510(k)

Full name
Cybrex Carbamazepine
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 is the Cybrex Carbamazepine device used for in a clinical setting?

    The Cybrex Carbamazepine (K802902) is an enzyme immunoassay designed specifically for the qualitative detection of carbamazepine in biological specimens. It is used in clinical toxicology to identify whether carbamazepine—a medication for epilepsy and bipolar disorder—is present in a patient’s sample, helping to confirm exposure or overdose cases.

  • Is this device intended for reuse, or is it single-use only?

    The Cybrex Carbamazepine is intended for single-use only in clinical laboratory settings. This ensures accuracy and reliability, as reuse could compromise test integrity and regulatory compliance.

  • How should I store the Cybrex Carbamazepine kit to maintain its performance?

    The device requires proper storage as per manufacturer guidelines to preserve accuracy and reliability. While specific conditions (e.g., temperature, humidity) aren’t detailed here, adherence to Abbott Laboratories’ instructions is critical to avoid degradation before use.

  • What regulatory pathway was followed for FDA clearance of this device?

    The Cybrex Carbamazepine received FDA 510(k) clearance under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent (SESE). It falls under the Clinical Toxicology advisory committee (IM) and is classified as an Enzyme Immunoassay with product code KLT, regulated under 21 CFR 862.3645.

  • Can this device be used with MRI equipment, or does it have any MRI-related restrictions?

    The Cybrex Carbamazepine is not intended for MRI use. This exclusion is explicitly noted in the device’s specifications, meaning it should not be placed in or near MRI environments where electromagnetic interference could affect performance or safety.