# K020871: Vitek 2 Antimircrobial Susceptibility Test System for Levofloxacin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Mar 29, 2002 after 91 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Trimethoprim/Sulfamethoxazole: named in the summary without a submission number

## Indications for use
The VITEK® 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin is intended for use with the VITEK® 2 System in clinical laboratories as an in vitro test to determine the susceptibility of Streptococcus pneumoniae to antimicrobial agents. The antimicrobial panel presented in the VITEK® 2 AST card is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml.

Source page: https://510kreport.com/device/K020871
Methodology: https://510kreport.com/methodology