# K992993: Etest for Quinupristin/Dalfopristin

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biodisk
- Decided: Nov 16, 1999 after 70 days
- Product code: LTX (Discs, Elution)
- Device class: 2
- Regulation: 21 CFR 866.1620
- 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 antimicrohial susceptibility ot both non-fastidious Gram negative and Gram positive aerobic bacteria, such as fnterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneurnococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used (0 determine the Minimum Inhibitory Concentration (MIC) in pg/inl of individual antibiotics against bacteria as tested on agar media by overnight incubdtion. This Etest 510(k) application is for MIC determination of Quinupristin/Dalfopristin in the range of 0.002 - 32 pg/ml with multi-resistant, including Vancomycin resistant, Enterococcus faecium and Methicillin-susceptible Staphylococcus aureus.

Source page: https://510kreport.com/device/K992993
Methodology: https://510kreport.com/methodology