# K152075: VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Apr 15, 2016 after 263 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: 7 generations back to K032788 (2003). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121546: Vitek 2 Gram Negative Doxycycline, bioMerieux, Inc. (2012) Summary page 5.

## Most influential descendants
- K161437: VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) (2017), 0 descendants of its own

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0861-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
VITEK® 2 Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Gram Negative Ertapenem is a quantitative test. Ertapenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis In vitro data available but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca (excluding ESBL producing isolates) Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii Serratia marcescens The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems 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 spp. and clinically significant yeast.

Source page: https://510kreport.com/device/K152075
Methodology: https://510kreport.com/methodology