# K072695: Vitek 2 Gram Positive Tigecycline

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Nov 16, 2007 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K032766 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050075: Vitek 2 Gram Positive Daptomycin, bioMerieux, Inc. (2005) Summary page 1.

## Indications for use
VITEK® 2 Gram Positive Tigecycline is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Tigecycline is a qualitative test. Tigecycline has been shown to be active against the organisms listed below according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterococcus faecalis (Vancomycin-susceptible isolates only) Staphylococcus aureus (methicillin-susceptible and -resistant isolates) Streptococcus agalactiae Active in vitro but their clinical significance is unknown: Enterococcus faecium (Vancomycin susceptible and resistant isolates) Staphylococcus epidermidis Staphylococcus haemolyticus Enterococcus casseliflavus. The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact 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 agalactiae, and S. pneumoniae.

Source page: https://510kreport.com/device/K072695
Methodology: https://510kreport.com/methodology