# K122547: Gram Postitve Clindamycin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 15, 2012 after 55 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 K032766 (2003). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032766: Vitek 2 Gram Positive Linezolid, bioMerieux, Inc. (2003) Summary page 1.

## Most influential descendants
- K141149: Vitek 2 Ast GP Ceftaroline (2014), 4 descendants of its own
- K190616: VITEK 2 AST-Gram Positive Dalbavancin (<=  0.015 - >= 1 µg/mL) (2019), 3 descendants of its own
- K212243: VITEK 2 AST- Gram Positive Telavancin (<=0.015 -  >=1 µg/mL) (2022), 0 descendants of its own
- K202396: VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) (2021), 0 descendants of its own
- K200590: VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) (2020), 0 descendants of its own

## Indications for use
VITEK® 2 AST-GP Clindlamycin is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epiderniidis. VITEK 2 AST-GP Clindlamycin is a quantitative test 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. Clindamycin has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections Staphylococcus aureus (methicillin-susceptible strains) and Staphylococcus epiderniidis (methicillin-susceptible strains) 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 apop., Enterococcus spp., Streptococcus agralactiae, and S. pneumoniae.

Source page: https://510kreport.com/device/K122547
Methodology: https://510kreport.com/methodology