# K041982: Vitek 2 Gram Negative Ertapenem

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Sep 14, 2004 after 53 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032788 (2003). 1 ancestor in all.
29 later devices descend from it; 3 cite it directly.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032788: Vitek 2 Gram Negative Gatifloxacin, bioMerieux, Inc. (2003) Summary page 1.

## Most influential descendants
- K072038: Vitek 2 Gram Negative Levofloxacin (2007), 26 descendants of its own
- K082346: Vitek 2 Gram Negative Doripenem (2009), 22 descendants of its own
- K091899: Vitek 2 Gram Negative Meropenem (2009), 21 descendants of its own
- K103752: Vitek 2 Systems (PC) 5.02 Software (2011), 19 descendants of its own
- K121546: Vitek 2 Gram Negative Doxycycline (2012), 15 descendants of its own

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0838-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 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 2 Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris, and Serratia marcescens. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Source page: https://510kreport.com/device/K041982
Methodology: https://510kreport.com/methodology