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System U3 for Ampicillin

by Ab Biodisk Sweden 510(k)

510(k) K984087

Product code JWY

Overview

The System U3 for Ampicillin is a Manual Antimicrobial Susceptibility Test System (Product Code JWY), designed for in vitro determination of bacterial susceptibility to ampicillin. It falls under the classification of microbiology diagnostic devices, enabling laboratories to assess whether bacterial isolates are resistant or susceptible to this beta-lactam antibiotic. The system adheres to regulatory standards for antimicrobial testing, ensuring reproducible and clinically relevant results for infection control and treatment guidance.

This device is supplied as a manual test kit for single-use in clinical microbiology laboratories. It is intended for use in non-sterile environments, as it is not sterile-packaged but validated for accurate performance under controlled laboratory conditions. The System U3 complies with FDA 510(k) clearance (K984087) under Class II regulatory classification, with no MRI safety considerations. Storage and handling follow standard microbiological protocols to maintain test integrity, and its use is governed by regulatory requirements for antimicrobial susceptibility testing systems.

Summary written by AI from registry data, 1 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984087 Date8 Feb 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k) · synced 6 Oct 2026

510(k) Number
FDA Product Code
JWY
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the System U3 for Ampicillin used for?

    The System U3 for Ampicillin is designed for in vitro determination of bacterial susceptibility to ampicillin, a beta-lactam antibiotic. It helps laboratories assess whether bacterial isolates are resistant or susceptible to this antibiotic, supporting infection control and guiding appropriate treatment decisions.

  • Is the System U3 for Ampicillin sterile?

    No, the System U3 for Ampicillin is not sterile-packaged. It is validated for accurate performance in non-sterile environments under controlled laboratory conditions, adhering to standard microbiological protocols.

  • How is the System U3 for Ampicillin supplied?

    The System U3 for Ampicillin is supplied as a manual test kit intended for single-use in clinical microbiology laboratories. It is not intended for reuse and must be handled according to standard microbiological practices to maintain test integrity.

  • What regulatory clearance does the System U3 for Ampicillin hold?

    The System U3 for Ampicillin holds FDA 510(k) clearance under the classification of Manual Antimicrobial Susceptibility Test Systems (Product Code JWY). It is classified as substantially equivalent and falls under the regulatory category for microbiology diagnostic devices.

  • How should the System U3 for Ampicillin be stored?

    Storage and handling of the System U3 for Ampicillin follow standard microbiological protocols to preserve test accuracy. Since it is not sterile, it should be stored in a controlled laboratory environment, away from contaminants, and used within the specified conditions outlined in the device instructions.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K984087 24 fields · synced 6 Oct 2026