# K260281: VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux
- Decided: Mar 26, 2026 after 56 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: 5 generations back to K031865 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232201: VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin, bioMerieux, Inc. (2023) Summary page 5.

## Indications for use
VITEK 2 AST-Streptococcus Cefuroxime (≤0.125 - ≥8) 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 Cefuroxime (≤0.125 - ≥8) is a quantitative test. Testing is indicated for Streptococcus pneumoniae as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). VITEK 2 AST-Streptococcus Cefuroxime (≤0.125 - ≥8) has demonstrated acceptable performance with the following organism: Streptococcus pneumoniae The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used 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/K260281
Methodology: https://510kreport.com/methodology