# K223481: VITEK® 2 Streptococcus Tetracycline (<=0.25 -  >=16 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 3, 2023 after 77 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: 4 generations back to K031865 (2003). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111893: Vitek (R) 2 Streptococcus Tetracycline, bioMerieux, Inc. (2012) Summary page 4.

## Indications for use
VITEK® 2 Streptococcus Tetracycline is designed for antimicrobial susceptibility testing of Streptococcus species and 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. VITEK® 2 Streptococcus Tetracycline is a quantitative test. Tetracycline has been shown to be active against the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Streptococcus pneumoniae Streptococcus pyogenes* *The VITEK® 2 Streptococcus Susceptibility Card also reports the susceptibility of the following additional organisms as listed on the FDA Susceptibility Test Interpretative Criteria website (STIC): Streptococcus spp. ß-Hemolytic Group (other than S. pyogenes). 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/K223481
Methodology: https://510kreport.com/methodology