# K220805: VITEK 2 AST-Gram Positive Cefoxitin Screen

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 13, 2022 after 209 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.
No later device cites it as a predicate yet.
1 of 2 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 4.

## Indications for use
VITEK® 2 AST-Gram Positive Cefoxitin Screen test is designed to predict mecA-mediated oxacillin resistance in Staphylococcus spp. 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 Gram-Positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and Streptococcus agalactiae to antimicrobial agents when used as instructed.

Source page: https://510kreport.com/device/K220805
Methodology: https://510kreport.com/methodology