# K031865: Vitek 2 Gram Positive Moxifloxacin for Strepococcus Pneumoniae

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Aug 13, 2003 after 57 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.
26 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K050510: Echoview/Shimasonic Diagnostic Ultrasound System, Model Sdu-1100, Shimadzu Medical Systems (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K053186: Vitek 2 Gram Positive Telithromycin for Streptococcus Pneumoniae (2005), 24 descendants of its own
- K063597: Vitek 2 Gram Positive Amoxicillin for Streptococcus Pneumoniae (2007), 20 descendants of its own
- K112000: Vitek 2 Streptococcus Penicillin (2011), 3 descendants of its own
- K232201: VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (2023), 2 descendants of its own
- K121863: Vitek 2 Ast-ST Cefotaxime (2012), 2 descendants of its own

## Indications for use
VITEK@2 Gram Positive Moxifloxacin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the VITEK? 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Source page: https://510kreport.com/device/K031865
Methodology: https://510kreport.com/methodology