Sceptor Pseudomonas Plus MIC Panel

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

510(k) Number

K854098 ↗

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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• What is the Sceptor Pseudomonas Plus MIC Panel used for?

  This panel is designed specifically for manual antimicrobial susceptibility testing of *Pseudomonas* species in clinical microbiology labs. It helps determine the minimum inhibitory concentration (MIC) of antimicrobial agents, enabling targeted antibiotic therapy selection and improving infection control strategies. By standardizing resistance assessment, it supports evidence-based decisions to combat bacterial resistance patterns.

• How is the Sceptor Pseudomonas Plus MIC Panel supplied and intended for use?

  The panel is supplied as a single-use diagnostic reagent, ensuring sterility and consistency for each test. It is intended exclusively for use in clinical microbiology laboratories where microbiologists can perform standardized MIC testing. The single-use format eliminates cross-contamination risks and aligns with best practices for aseptic handling and microbiological safety.

• Is the Sceptor Pseudomonas Plus MIC Panel sterile and reusable?

  The panel is supplied in a sterile, single-use format, meaning each unit is intended for one test cycle only. Sterility is critical for accurate MIC results, and reuse is not recommended or supported by the manufacturer. Laboratories must adhere to sterility protocols during handling to maintain test integrity and prevent contamination.

• What regulatory pathway does the Sceptor Pseudomonas Plus MIC Panel follow?

  The panel is classified under FDA product code JWY and has received 510(k) clearance (K883554) as a Class II device. This clearance confirms it meets FDA’s special controls for manual antimicrobial susceptibility testing systems, ensuring compliance with safety and performance standards for clinical use. The Microbiology (MI) Advisory Committee reviewed its substantial equivalence to prior-generation devices.

• Are there any special storage or handling requirements for the Sceptor Pseudomonas Plus MIC Panel?

  The panel must be stored according to the manufacturer’s guidelines to preserve sterility and test accuracy. Proper storage typically involves refrigeration (if applicable) and protection from light or moisture until use. Laboratories should follow standard microbiological practices, including aseptic technique, to prevent contamination during handling. Adherence to these protocols ensures reliable MIC results and extends the panel’s shelf life.