# K080201: Vitek 2 Gram Positive Inducible Clindamycin Resistance

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Apr 30, 2008 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: 1 generation back to K053097 (2005). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K053097: Vitek 2 Gram Positive Cefoxitin Screen, bioMerieux, Inc. (2005) Summary page 1.

## Most influential descendants
- K111909: Vitek 2 Streptococcus Inducible Clindamycin Resistance (2011), 2 descendants of its own
- 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 Gram Positive Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus species. VITEK 2 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 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/K080201
Methodology: https://510kreport.com/methodology