# K050076: Vitek 2 Gram Positive Ertapenem

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 18, 2005 after 37 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 K032788 (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)
- K032788: Vitek 2 Gram Negative Gatifloxacin, bioMerieux, Inc. (2003) Summary page 1.

## 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 Positive Ertapenem is designed for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin susceptible strains only), and Streptococcus agalactiae. VITEK 2 Gram Positive Ertapenem is a qualitative test. 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/K050076
Methodology: https://510kreport.com/methodology