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DuPont Dimension Gentamicin Method

by E.I. Dupont DE Nemours & Co., Inc.

510(k) K904305

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904305 Date15 Oct 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Dupont Dimension(R) Gentamicin(Gent) Method
510(k) Number
FDA Product Code
LCD
Device Class
Class II
Regulation
21 CFR Part 862.3450
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The DuPont Dimension Gentamicin Method is an enzyme immunoassay device designed to quantitatively measure gentamicin concentrations in human specimens. As classified under the FDA’s nomenclature, it functions as a diagnostic test for determining gentamicin levels, aiding in the clinical management of antibiotic therapy and monitoring for potential toxicity or overdose.

This device is intended for in vitro diagnostic use in clinical toxicology settings, supplied as a single-use reagent kit. It requires no special storage conditions beyond standard laboratory refrigeration and is regulated under FDA 510(k) clearance (K904305) as a Class II device. The method adheres to regulatory standards outlined in 21 CFR 862.3450, ensuring compliance with FDA requirements for enzyme immunoassay systems.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the DuPont Dimension Gentamicin Method used for?

    The DuPont Dimension Gentamicin Method is an enzyme immunoassay designed to quantitatively measure gentamicin concentrations in human specimens. It supports clinical decision-making by helping clinicians monitor antibiotic therapy levels and assess potential toxicity or overdose risks in patients receiving gentamicin treatment.

  • How is the DuPont Dimension Gentamicin Method supplied?

    This device is supplied as a single-use reagent kit, meaning each kit is intended for one-time use in a laboratory setting. This design ensures consistency and reduces the risk of cross-contamination between tests.

  • What storage conditions are required for the DuPont Dimension Gentamicin Method?

    The kit does not require special storage conditions beyond standard laboratory refrigeration. This makes it convenient for clinical toxicology labs to maintain without additional infrastructure.

  • Is the DuPont Dimension Gentamicin Method reusable or single-use?

    The device is explicitly designed for single-use only. This aligns with best practices in clinical diagnostics to prevent contamination and ensure accurate, reliable results for each patient specimen.

  • What regulatory pathway does the DuPont Dimension Gentamicin Method follow?

    The DuPont Dimension Gentamicin Method is regulated under the FDA’s 510(k) clearance process as a Class II device, with clearance number K904305. It adheres to regulatory standards outlined in 21 CFR 862.3450, ensuring compliance with FDA requirements for enzyme immunoassay systems used in clinical toxicology.