# K083383: Vitek 2 Gram Positive Erythromycin for Streptococcus Pneumoniae

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 18, 2009 after 93 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 K031865 (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)
- K053186: Vitek 2 Gram Positive Telithromycin for Streptococcus Pneumoniae, bioMerieux, Inc. (2005) Summary page 1.

## Indications for use
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 sp, Enterococcus spp:, Streptocpccus agalactiae,and S. pneumoniae: VITEK® 2 Gram Positive Erythromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibilitytesting of Gram positive Streptococcuspneumoniae and is intended for use with the VITEe 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Positive Erythromycin for Streptococcus pneumoniae is a qualitative test. This submission is for the addition of an intermediate interpretive criteria. Erythromcyin has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Streptococcus pneumoniae

Source page: https://510kreport.com/device/K083383
Methodology: https://510kreport.com/methodology