# K111909: Vitek 2 Streptococcus Inducible Clindamycin Resistance

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 18, 2011 after 105 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 K053097 (2005). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080201: Vitek 2 Gram Positive Inducible Clindamycin Resistance, bioMerieux, Inc. (2008) Summary page 1.

## Most influential descendants
- K260282: VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (2026), 0 descendants of its own
- K181766: VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance (2018), 0 descendants of its own

## Indications for use
VITEK® 2 Streptococcus Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Streptococcus agalactiae and Streptococcus pyogenes. VITEK® 2 Streptococcus Inducible Clindamycin Resistance 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 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 yeast.

Source page: https://510kreport.com/device/K111909
Methodology: https://510kreport.com/methodology