Skip to content

Gentamicin Fluorescent Immunoassay

by American Diagnostic Corp.

510(k) K813539

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK813539 Date31 Dec 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LCQ
Device class
Class II
Regulation
21 CFR Part 862.3450
Advisory committee
Clinical Toxicology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Gentamicin Fluorescent Immunoassay is a Fluorescent Immunoassay (Product Code LCQ) designed to quantitatively measure gentamicin concentrations in human specimens. It employs fluorescent technology to detect and assess levels of this aminoglycoside antibiotic, aiding in clinical toxicology assessments such as overdose diagnosis and therapeutic drug monitoring.

This device is intended for in vitro diagnostic use in clinical laboratories, supplied as a single-use kit. It requires no special storage conditions beyond refrigeration and is classified as a Class II medical device under FDA regulations. Authorized under 510(k) clearance K813539, it adheres to regulatory standards for fluorescent immunoassays, ensuring reliable measurement of gentamicin in serum or plasma samples.

Other devices from American Diagnostic Corporation

See all devices from American Diagnostic Corporation →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical scenarios is this immunoassay primarily used for in a lab setting?

    This Gentamicin Fluorescent Immunoassay is designed for quantitative measurement of gentamicin levels in human serum or plasma, making it useful for clinical toxicology assessments. Clinicians rely on it to diagnose gentamicin overdoses or monitor therapeutic drug concentrations to ensure safe and effective antibiotic treatment.

  • How is the Gentamicin Fluorescent Immunoassay supplied, and is it reusable?

    The device is supplied as a single-use kit, meaning each kit is intended for one testing procedure. This design ensures consistency and reduces the risk of cross-contamination, which is critical for accurate diagnostic results in clinical laboratories.

  • What storage conditions are required for this immunoassay kit?

    The kit does not require any special storage conditions beyond standard refrigeration. This makes it convenient for laboratories to maintain without needing additional infrastructure, ensuring availability when needed for testing.

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

    The Gentamicin Fluorescent Immunoassay was cleared through a Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) under the Clinical Toxicology advisory committee (TX). The clearance number is K813539, and it is classified as a Class II medical device.