# K053186: Vitek 2 Gram Positive Telithromycin for Streptococcus Pneumoniae

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Dec 1, 2005 after 17 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 K031865 (2003). 1 ancestor in all.
24 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031865: Vitek 2 Gram Positive Moxifloxacin for Strepococcus Pneumoniae, bioMerieux, Inc. (2003) Summary page 1.

## Most influential descendants
- K063597: Vitek 2 Gram Positive Amoxicillin for Streptococcus Pneumoniae (2007), 20 descendants of its own
- K112000: Vitek 2 Streptococcus Penicillin (2011), 3 descendants of its own
- K232201: VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (2023), 2 descendants of its own
- K121863: Vitek 2 Ast-ST Cefotaxime (2012), 2 descendants of its own
- K122359: Vitek 2 Strptococcus Ceftriaxone (2012), 1 descendant of its own

## Indications for use
VITEK® 2 Gram Positive Telithromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 Gram Positive Telithromycin for Streptococcus pneumoniae is a qualitative test. It 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. The VITEKI 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/K053186
Methodology: https://510kreport.com/methodology