# K980345: Etest Ceftriaxone

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biodisk
- Decided: May 27, 1998 after 118 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 2 (0 Class I)
- 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.

## Recalls of this device
- Dec 15, 2016 · Class II · Z-1523-2017: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
- Dec 15, 2016 · Class II · Z-1532-2017: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

## 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 Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in pg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation. This application is for MIC determination of Ceftriaxone in the range of 0.016 - 256 pg/ml or 0.002 - 32 pg/ml for Streptococcus spp. Previously cleared applications include H.-influenzae and S. pneumoniae.

Source page: https://510kreport.com/device/K980345
Methodology: https://510kreport.com/methodology