# K081325: Etest Doripenem - Antimicrobial Susceptibility Test - Mic at 0.002-32 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biodisk
- Decided: Jul 24, 2008 after 73 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 1 (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-1526-2017: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

## Indications for use
This submission is for Etest® Doripenem for MIC determinations across 0.002-32 /g/mL with Gram negative aerobic bacteria such as Enterobaceiaeae,Adnetobater baunii, Pseudormnas aemrginosa and Gram negative anaerobic bacteria such as Baaewides caaae,B. frag/&, B. taiotaonizrn B. un/fomis and B. zudgatus. Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enoeroaceae Pseudm'nas, Stapbhwcu~ss and Entercxm species and fastidious bacteria, such as anaerobes, N. gaionbcae,S. prourarm/ Streptoxw and Haenvpbh/us species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration v (MIQ in g/mL of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.

Source page: https://510kreport.com/device/K081325
Methodology: https://510kreport.com/methodology