MIC Antibiotic Test Panels

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

Panels, test, susceptibility, antimicrobial

PMA Number

N50494 ↗

FDA Product Code

LTT

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

APPR Approved

PMA Supplement

S009

• Pasco Mic and Mic/Id Panels, Quinupristin/Dalfopristin

  Class II

  FDA 510(k) K992717 Active Cleared 2 Nov 1999

• Pasco Mic and Mic/Id Panels

  Class II

  FDA 510(k) K944517 Active Cleared 19 Oct 1994

• Pasco Mic and Mic/Id Panels/ Cefdinir

  Class II

  FDA 510(k) K982156 Active Cleared 29 Jul 1998

• Pasco Mic and Mic/Id Panels, Vancomycin

  Class II

  FDA 510(k) K992296 Active Cleared 21 Sep 1999

• Pasco Mic Panels/ Gent & Strep Synergy

  Class II

  FDA 510(k) K934380 Active Cleared 27 Jan 1994

• Pasco Mic and Mic/Id Panels (Ofloxacin)

  Class II

  FDA 510(k) K992077 Active Cleared 3 Sep 1999

See all devices from Pasco Laboratories, Inc. →

• What is the primary purpose of the MIC Antibiotic Test Panels in a clinical setting?

  The MIC Antibiotic Test Panels are designed to determine the minimum inhibitory concentration (MIC) of antibiotics against bacterial isolates. This helps clinicians assess whether a bacterial infection is resistant or sensitive to specific antimicrobial agents, guiding appropriate treatment decisions in microbiology laboratories.

• Are the MIC Antibiotic Test Panels intended for single-use or repeated use?

  These panels are explicitly labeled as sterile and single-use diagnostic aids. They must not be reused to ensure accurate and reliable test results, as reuse could compromise sterility and compromise the integrity of the antimicrobial susceptibility testing.

• How should the MIC Antibiotic Test Panels be stored to maintain their effectiveness?

  Storage and handling must follow standard microbiological practices to preserve sterility and accuracy. While specific storage conditions aren’t detailed here, the panels are sterile diagnostic tools, so they should be kept in a clean, dry environment away from direct contamination until use, per general microbiology lab protocols.

• What regulatory pathway was followed for the approval of the MIC Antibiotic Test Panels?

  The MIC Antibiotic Test Panels were authorized through the FDA’s Premarket Approval (PMA) process, indicated by the PMA number N50494. This pathway is typically used for higher-risk devices, and the panels fall under FDA device class 2, regulated under 21 CFR 866.1640.

• What types of bacterial isolates can these panels test for antibiotic susceptibility?

  While the exact bacterial isolates aren’t specified in the provided data, these panels are antimicrobial susceptibility test panels designed for general use in microbiology laboratories to evaluate bacterial resistance or sensitivity to antibiotics. They are not limited to specific pathogens but are intended for routine susceptibility testing in clinical settings.