Potassium Penicillin G Diag Sys Powder
by Pfizer Inc. PMA
Active
PMA N50042
Overview
This device is a Susceptibility Test Powder, Antimicrobial, used for in vitro determination of bacterial susceptibility to potassium penicillin G. It falls under the classification of antimicrobial susceptibility testing reagents, enabling microbiologists to assess microbial resistance patterns in clinical laboratories.
The powder is supplied as a sterile, single-use diagnostic system intended for microbiological testing in clinical settings. It is classified as a Class II medical device under FDA regulations (866.1640) and requires authorization via a Premarket Approval (PMA) application (N50042). Storage and handling must comply with standard microbiological practices to ensure accuracy and sterility.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberN50042 | Date27 Feb 1970 | 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- Withdrawn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
- Generic Name
- Susceptibility test powders, antimicrobial
- FDA applicant
- Pfizer, Inc.
- PMA Number
- FDA Product Code
- JTT
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1640
- Advisory Committee
- Microbiology
- FDA Decision
- APRL
Other devices from Pfizer Inc.
Questions
What is the primary use of the Potassium Penicillin G Diagnostic System Powder in a clinical lab setting?
This device is designed specifically for in vitro testing to determine how susceptible bacteria are to potassium penicillin G. Microbiologists use it to evaluate resistance patterns, helping guide appropriate antibiotic treatment decisions in clinical settings.
Is this product meant for repeated use, or is it single-use only?
The Potassium Penicillin G Diagnostic System Powder is explicitly labeled as a single-use diagnostic system. Each vial is intended for one microbiological test to maintain accuracy and sterility, aligning with standard microbiological practices.
How should this product be stored, and what precautions should be taken?
Storage must follow standard microbiological practices to preserve sterility and effectiveness. Since it’s a sterile, single-use powder, it should be kept in a clean, dry environment away from direct light and extreme temperatures until use, as per typical laboratory protocols for susceptibility testing reagents.
What regulatory pathway was followed for this device’s approval, and what does that mean for its use?
This device was authorized through the FDA’s Premarket Approval (PMA) process, specifically under PMA number N50042. This means it underwent rigorous review by the FDA’s Microbiology Devices Advisory Committee (MI) to ensure safety and effectiveness before clinical use, ensuring it meets stringent standards for antimicrobial susceptibility testing.