# K052366: Etest Tigecycline Gram Positive and Gram Negative Aerobic Bacteria, Streptococcus SPP. and Anaerobic Bacteria

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biodisk
- Decided: Oct 13, 2005 after 45 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This submission is for the addition of Tigecycline to the Etest® product range for MIC determination across 0.016-256 µg/mL with Gram positive and Gram negative aerobic bacteria, Streptococcus species other than S. pneumoniae and anaerobic bacteria. Etest® is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus, Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in µg/mL of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.

Source page: https://510kreport.com/device/K052366
Methodology: https://510kreport.com/methodology