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Du Pont Gentamicin Assay Reagents

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

510(k) K850060

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 NumberK850060 Date18 Jan 1985ClearedStatusActive

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  • Withdrawn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)

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 Du Pont Gentamicin Assay Reagents are an enzyme immunoassay system designed to quantitatively measure gentamicin concentrations in human specimens. This device aids in the clinical assessment of gentamicin levels, supporting the diagnosis of overdose and the optimization of antibiotic therapy by providing precise analytical results.

Intended for use in clinical toxicology settings, the reagents are supplied as a diagnostic kit for in vitro laboratory testing. They are classified as a Class II device under 21 CFR 862.3450 and have received FDA 510(k) clearance (K850060) as substantially equivalent to a predicate device. The assay is non-sterile and intended for single-use per the manufacturer’s specifications.

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 Du Pont Gentamicin Assay Reagents used for?

    The Du Pont Gentamicin Assay Reagents are designed for in vitro laboratory testing to quantitatively measure gentamicin concentrations in human specimens. This helps clinicians assess gentamicin levels, detect potential overdoses, and optimize antibiotic therapy by providing accurate analytical results in clinical toxicology settings.

  • How is the Du Pont Gentamicin Assay Reagents supplied?

    The reagents are supplied as a diagnostic kit for single-use per the manufacturer’s specifications. Each kit contains all necessary components for performing the enzyme immunoassay in a laboratory setting, ensuring precise and reliable measurements of gentamicin levels.

  • Is the Du Pont Gentamicin Assay Reagents sterile?

    No, the Du Pont Gentamicin Assay Reagents are classified as non-sterile. This is explicitly stated in the manufacturer’s specifications, and the device is intended for use in controlled laboratory environments where sterility is not required for the assay procedure.

  • Can the Du Pont Gentamicin Assay Reagents be reused?

    No, the Du Pont Gentamicin Assay Reagents are intended for single-use only. Reusing the reagents could compromise the accuracy and reliability of the assay results, potentially leading to incorrect clinical assessments of gentamicin levels.

  • What regulatory pathway does the Du Pont Gentamicin Assay Reagents follow?

    The Du Pont Gentamicin Assay Reagents have received FDA 510(k) clearance (K850060) as substantially equivalent to a predicate device. This classification under 21 CFR 862.3450 confirms its compliance with regulatory standards for enzyme immunoassay devices used in clinical toxicology.