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MicroScan Microstrep Plus Panel New Antimicrobial-Erythromycin

by Dade Microscan, Inc. 510(k)

Active United States

510(k) K021078

Overview

The MicroScan Microstrep Plus Panel New Antimicrobial-Erythromycin is a microbiology test panel used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. It is a 96-well plastic dish containing dehydrated antimicrobial agents, specifically including erythromycin in the range of 0.015 to 2 Mcg/mL.

The panel is rehydrated with Mueller-Hinton broth supplemented with 2-5% lysed horse blood and inoculated with standardized bacterial suspensions of approximately 5 x 10⁵ CFU/mL. After inoculation, panels are incubated for 20-24 hours at 35°C ± 1°C in a non-CO₂ incubator and read visually according to the package insert. It is supplied as a reusable or single-use device (as implied by rehydration and reuse in testing workflows) and is authorized under FDA 510(k) clearance K021078.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK021078 Date6 Jun 2002ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LTT
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 MicroScan Microstrep Plus Panel New Antimicrobial-Erythromycin used for?

    It is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae, by testing the effectiveness of antibiotics like erythromycin against bacterial isolates.

  • How is the MicroScan Microstrep Plus Panel New Antimicrobial-Erythromycin supplied and prepared for use?

    It is supplied as a 96-well plastic dish containing dehydrated antimicrobial agents, including erythromycin in the range of 0.015 to 2 Mcg/mL, and is rehydrated with Mueller-Hinton broth supplemented with 2-5% lysed horse blood before inoculation with standardized bacterial suspensions.

  • Is the MicroScan Microstrep Plus Panel New Antimicrobial-Erythromycin reusable or single-use?

    The panel is described as reusable or single-use, as implied by the rehydration process and its use in testing workflows where multiple tests may be conducted from the same panel after proper handling and reconditioning.

  • What are the incubation conditions for the MicroScan Microstrep Plus Panel New Antimicrobial-Erythromycin?

    After inoculation, the panel is incubated for 20-24 hours at 35°C ± 1°C in a non-CO₂ incubator, followed by visual reading according to the package insert to determine antimicrobial susceptibility results.

  • What regulatory authorization does the MicroScan Microstrep Plus Panel New Antimicrobial-Erythromycin have?

    It is authorized under FDA 510(k) clearance K021078, which was granted on June 6, 2002, following a traditional submission process based on substantial equivalence to a legally marketed device.