# K043230: Vitek Gram Negative Susceptibility (GNS) Card for Ertapenem

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Dec 30, 2004 after 38 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032711 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032711: Vitek Gram Negative Gatifloxacin, bioMerieux, Inc. (2003) Summary page 1.

## Indications for use
The VITEK® Gram Negative Susceptibility Test is intended to be used with the VITEK® System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae,and S. pneumoniae. VITEK® Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia col, Klebsiella pneumoniae, Citrobacterfreundii, Citrobacterkoseri, Enterobacter aerogenes, Enterobactercloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris and Serratia marcescens. VITEK Gram Negative Ertapenem is for qualitative testing only. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Source page: https://510kreport.com/device/K043230
Methodology: https://510kreport.com/methodology