# K260282: VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Apr 15, 2026 after 76 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 5.

## Indications for use
VITEK 2 AST Streptococcus Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Streptococcus species and is intended for use with the VITEK 2 Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Streptococcus Inducible Clindamycin Resistance is a qualitative test. Testing is indicated for Streptococcus pneumoniae and Streptococcus spp. β-hemolytic group. VITEK 2 AST Streptococcus Inducible Clindamycin Resistance has demonstrated acceptable performance with the following organisms: Streptococcus pneumoniae Streptococcus spp. β-hemolytic group (Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus canis, Streptococcus dysgalactiae equisimilis, Streptococcus equi zooepidemicus) The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Streptococcus pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.

Source page: https://510kreport.com/device/K260282
Methodology: https://510kreport.com/methodology