Polymyxin B Sulfate Susceptibility Testing System
by Pfizer Inc. PMA
Active
PMA N50061
Overview
This device is an Automated Antimicrobial Susceptibility Test System for Short Incubation, classified under Class II medical devices. It is designed to determine the susceptibility of microorganisms to polymyxin B sulfate, aiding in the selection of appropriate antimicrobial therapy by providing quantitative resistance profiles.
The system is intended for use in microbiology laboratories and is supplied as a kit for automated testing. It is not specified as single-use or reusable, but compliance with standard microbiological practices is required. The device operates under FDA Premarket Approval (PMA) and is regulated under regulation number 866.1645, with PMA number N50061. No MRI safety or sterility specifications are provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberN50061 | Date24 Nov 1969 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Polymyxin B Sulfate Susceptibility Testing
- Generic Name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- FDA applicant
- Pfizer, Inc.
- PMA Number
- FDA Product Code
- LON
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1645
- Advisory Committee
- Microbiology
- FDA Decision
- APRL
Other devices from Pfizer Inc.
Questions
What is the primary purpose of this automated susceptibility testing system, and how does it help in clinical decision-making?
This system is designed to determine whether microorganisms are susceptible or resistant to polymyxin B sulfate, aiding clinicians in selecting the most effective antimicrobial therapy. By providing quantitative resistance profiles, it helps guide treatment choices in microbiology laboratories, ensuring targeted and evidence-based prescribing.
Is this device intended for single-use or can it be reused? What are the recommended handling practices?
The device is supplied as a kit for automated testing, but the data does not specify whether it is single-use or reusable. Standard microbiological practices must be followed to ensure accuracy and safety, including proper cleaning, sterilization (if applicable), and maintenance to prevent cross-contamination or degradation of results.
How is this system regulated, and what regulatory pathway was followed for its approval?
This device is classified as a Class II medical device under FDA regulation 866.1645 and was approved through the Premarket Approval (PMA) pathway, with PMA number N50061. The approval was granted by the FDA’s Microbiology (MI) advisory committee, ensuring its compliance with rigorous standards for antimicrobial susceptibility testing.
Are there any specific storage requirements mentioned for this automated testing system?
The provided data does not include explicit storage instructions for the device itself. However, as with most laboratory equipment, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain functionality and accuracy. Follow manufacturer guidelines for any accompanying consumables or reagents.
What types of microorganisms can this system test for susceptibility to polymyxin B sulfate?
While the system is specifically designed to test susceptibility to polymyxin B sulfate, the exact range of microorganisms it can evaluate is not detailed in the provided data. Typically, such systems are used for Gram-negative bacteria, including pathogens like *Pseudomonas aeruginosa* and *Acinetobacter* species, which are commonly resistant to other antibiotics and may require polymyxin B for treatment.