# K181766: VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Dec 10, 2018 after 160 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: 3 generations back to K053097 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111909: Vitek 2 Streptococcus Inducible Clindamycin Resistance, bioMerieux, Inc. (2011) Summary page 4.

## Indications for use
VITEK® 2 AST- Gram Positive Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus aureus, Staphylococcus lugdunensis, and Coagulase Negative Staphylococcus spp. VITEK® 2 AST- Gram Positive 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/K181766
Methodology: https://510kreport.com/methodology