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Vitek 2 Gram Positive Vancomycin

by Biomerieux, Inc.

510(k) K072668

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 NumberK072668 Date15 Oct 2007ClearedStatusActive

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  • Withdrawn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
LON
Device class
Class II
Regulation
21 CFR Part 866.1645
Advisory committee
Microbiology
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 Vitek 2 Gram Positive Vancomycin is an automated antimicrobial susceptibility test system designed for quantitative in vitro susceptibility testing. It is classified as a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation device, intended for use in microbiology laboratories to determine bacterial resistance to vancomycin in Enterococcus species, Staphylococcus species, and Streptococcus agalactiae.

This test is supplied as part of the Vitek 2 or Vitek 2 Compact Systems and is intended for single-use in clinical settings. The device measures antimicrobial susceptibility within a vancomycin concentration range of 0.5 to >32 µg/mL. It is regulated under FDA 510(k) clearance (K072668) and falls under the medical specialty of microbiology, adhering to regulatory standards for in vitro diagnostic devices.

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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 types of bacteria can the Vitek 2 Gram Positive Vancomycin test identify resistance to vancomycin for?

    This test is specifically designed to determine bacterial resistance to vancomycin in *Enterococcus* species, *Staphylococcus* species, and *Streptococcus agalactiae*. It is not intended for other bacterial types.

  • Is the Vitek 2 Gram Positive Vancomycin test meant for single-use or can it be reused?

    The test is supplied as part of the Vitek 2 or Vitek 2 Compact Systems and is explicitly intended for single-use in clinical microbiology laboratories. Reuse is not supported or validated.

  • What concentration range of vancomycin does the Vitek 2 Gram Positive Vancomycin test measure?

    The system quantifies antimicrobial susceptibility across a vancomycin concentration range of 0.5 to >32 µg/mL, enabling precise determination of bacterial resistance thresholds.

  • How is the Vitek 2 Gram Positive Vancomycin test regulated in the U.S.?

    The device is cleared by the FDA through a 510(k) pathway (K072668) under the classification of an automated antimicrobial susceptibility test system, adhering to regulatory standards for in vitro diagnostics.

  • What system does the Vitek 2 Gram Positive Vancomycin test integrate with for use?

    The test is supplied as part of the Vitek 2 or Vitek 2 Compact Systems, meaning it requires integration with one of these automated platforms for operation in microbiology laboratories.