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VITEK Gram Positive Susceptibility (GPS) Card for Ertapenem

by Biomerieux, Inc.

510(k) K042963

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 NumberK042963 Date13 Dec 2004ClearedStatusActive

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  • Withdrawn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, 26 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 Gram Positive Susceptibility (GPS) Card for Ertapenem is an automated antimicrobial susceptibility test system designed for use with the VITEK System. It is intended as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents for Gram-positive organisms, including Staphylococcus aureus and Streptococcus agalactiae.

The device is supplied for use in clinical laboratories and is classified as a Class II medical device under product code LON. It received FDA 510(k) clearance (K042963) on December 13, 2004, as substantially equivalent to a legally marketed predicate device. The card is used as instructed in the product labeling for antimicrobial susceptibility testing with short incubation protocols.

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Questions

AI-generated answers, 26 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 is the VITEK Gram Positive Susceptibility Card for Ertapenem used for?

    The VITEK Gram Positive Susceptibility (GPS) Card for Ertapenem is intended as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents for Gram-positive organisms, including Staphylococcus aureus and Streptococcus agalactiae, when used with the VITEK System.

  • How is the VITEK GPS Card for Ertapenem supplied and used in the laboratory?

    The device is supplied for use in clinical laboratories and is used as instructed in the product labeling for antimicrobial susceptibility testing with short incubation protocols on the VITEK System.

  • What regulatory pathway was used for the VITEK GPS Card for Ertapenem, and what is its classification?

    The device received FDA 510(k) clearance (K042963) on December 13, 2004, as substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device under product code LON.