Pasco MIC and MIC/ID Panels, Gemifloxacin (Strep)

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K032518 ↗

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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  Class I

  FDA 510(k) K260213 Active Cleared 28 May 2026

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  Class II

  FDA 510(k) K032153 Active Cleared 11 Sep 2003

• Bd Phoenix Automated Microbiology System-Meropenem 0.25-16 Ug/Ml

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  FDA 510(k) K031429 Active Cleared 6 Jun 2003

• Pasco Mic and Mic/Id Panels

  Class II

  FDA 510(k) K032259 Active Cleared 19 Aug 2003

• Bd Phoenix Automated Microbiology System - Norfloxacin 0.25 - 16 Ug/Ml

  Class II

  FDA 510(k) K030091 Active Cleared 28 Feb 2003

• BD PrepStain System

  Class III

  FDA PMA P970018 Active Approved 17 Jun 1999

• What is the Pasco MIC and MIC/ID Panels, Gemifloxacin (Strep) used for?

  These panels are designed to determine the minimum inhibitory concentration (MIC) of gemifloxacin against Streptococcus species. By measuring bacterial growth or colorimetric changes after incubation, clinicians can assess whether an organism is resistant or susceptible to the antibiotic. This helps guide appropriate treatment decisions in microbiology labs.

• How are the Pasco Gemifloxacin MIC/ID Panels supplied and prepared for use?

  The panels are supplied frozen and must be thawed before use. After thawing, they are inoculated with test organisms using a direct turbidity method. Incubation occurs for 16–24 hours at 35°C in a non-CO₂ environment to observe results.

• Are the Pasco Gemifloxacin MIC/ID Panels single-use or reusable?

  Each panel is intended for single-use only. This ensures accuracy and sterility, as reuse could compromise the integrity of the antimicrobial dilutions and introduce contamination risks.

• What storage conditions are required to maintain the panels’ integrity?

  The panels must be stored according to the manufacturer’s guidelines to preserve their frozen state and prevent degradation. Improper storage could alter the antimicrobial dilutions, leading to unreliable MIC results.

• What regulatory pathway does the Pasco Gemifloxacin MIC/ID Panels follow?

  The device is classified as a Class II medical device under FDA regulations and has received 510(k) clearance through a traditional review process. It is intended for in vitro diagnostic use in microbiology laboratories.