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The E Test, Modification

by Ab Biodisk Sweden(FDA 510(k) applicant) 510(k)

510(k) K913459 Product code JWY

Overview

The E Test, Modification is a manual antimicrobial susceptibility test system used to determine the susceptibility of microorganisms to antimicrobial agents. It consists of an impervious 5- by 50-mm strip containing a predefined antimicrobial gradient that is placed on an inoculated agar plate to perform susceptibility testing.

This device is regulated as a Class II medical device under regulation number 866.1640 and product code JWY. It received FDA 510(k) clearance on September 25, 1991, under submission K913459. The system is manufactured by Ab Biodisk in Solna, Sweden.

Summary written by AI from registry data, 25 Sep 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 26 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK913459 Date25 Sep 1991ClearedStatusActive

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 AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

6 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0823-2023 FDA Class II initiated 9 Nov 2022
    • Ongoing Z-0819-2023 FDA Class II initiated 9 Nov 2022

    As the temperature and time out of range was exceeded, product performances cannot be guaranteed

  • 2 recalls, same reason

    • Terminated Z-0265-2018 FDA Class II initiated 13 Apr 2017
    • Terminated Z-0264-2018 FDA Class II initiated 13 Apr 2017

    QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.

  • 2 recalls, same reason

    • Terminated Z-1522-2017 FDA Class II initiated 15 Dec 2016
    • Terminated Z-1530-2017 FDA Class II initiated 15 Dec 2016

    Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

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

Other devices from Ab Biodisk

See all devices from Ab Biodisk →

Questions

  • What is the primary function of The E Test, Modification?

    This device is a manual antimicrobial susceptibility test system designed to determine how susceptible specific microorganisms are to various antimicrobial agents.

  • How is the test system physically configured for use?

    The system consists of an impervious 5- by 50-mm strip that contains a predefined antimicrobial gradient. This strip is placed directly onto an inoculated agar plate to perform the susceptibility testing.

  • What is the regulatory status of this device?

    The E Test, Modification is regulated as a Class II medical device under regulation number 866.1640. It received FDA 510(k) clearance on September 25, 1991, under submission number K913459.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K913459 24 fields · synced 6 Oct 2026