# K984087: System U3 for Ampicillin

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biodisk
- Decided: Feb 8, 1999 after 84 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: System U3™ is a qualitative technique for antimicrobial susceptibility testing of non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation. This 510(k) application is for System U3/Ampicillin susceptibility testing based on the MIC breakpoints of Susceptible < 8 pg/ml, Intermediate 16 pg/ml and Resistant 2 32 pug/ml for use with non-fastidious Gram negative aerobic bacteria, Susceptible < 0.25 pg/ml and Resistant > 0.5 pg/ml for use with Staphylococcus, Susceptible < 8 pg/ml and Resistant > 16 pg/ml for use with Enterococcus.

Source page: https://510kreport.com/device/K984087
Methodology: https://510kreport.com/methodology