# K093604: Etest Moxifloxacin 0.002-32 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biomerieux
- Decided: Aug 25, 2010 after 278 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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 no predicate by number.

## Indications for use
This submission is for EtestO Moxifloxacin for MIfC determinations across 0.002-32 ptg/nl, with B. fragilis, B. thetaiotaomicron, C.perfibngens and Peptostreptococrusspp. EtestO is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Stap/~y/ococcus and Entenocorcus species and fastidious bacteria, such as anaerobes, N. gonorrboeae, S. pneumoniae, Streptococcus and H-aemop hi/ur species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in pg/mi. of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.

Source page: https://510kreport.com/device/K093604
Methodology: https://510kreport.com/methodology