# K021445: Etest Cefditoren for S. Pneumoniae and H. Influenzae

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biodisk
- Decided: Jun 6, 2002 after 31 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
For in vitro diagnostic use: 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 fnterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus, 5treptococcus, Gonococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (MIC) in pglml of individual antibiotics against bacteria as tested on agar media by overnight incubation. This Etest 51 O(k) application i s For MIC determination of Cefditoren in the range of 0.002 - 32 pgml with 5. pneumoniae (penicillin susceptible strains only) and H. in fluenzae.

Source page: https://510kreport.com/device/K021445
Methodology: https://510kreport.com/methodology