Antimicrobial Susceptibility Test System
by Abbott Laboratories PMA
Active
PMA N50525
Overview
This device is an Automated Antimicrobial Susceptibility Test System designed for short-incubation microbiological analysis. It automates the determination of bacterial susceptibility to antimicrobial agents, facilitating rapid and standardized testing in clinical microbiology laboratories. The system adheres to the nomenclature for automated antimicrobial susceptibility testing, ensuring compliance with regulatory microbiological standards.
The system is intended for use in clinical microbiology laboratories and is supplied as a reusable medical device. It operates under sterile conditions, with consumables and reagents provided separately for each test. Authorized under FDA PMA N50525, the device is classified under Device Class II (regulation number 866.1645) and is regulated for microbiological applications. No MRI safety or specific size constraints are noted in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberN50525 | Date15 Mar 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Antimicrobial Susceptability Test System
- Generic Name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- PMA Number
- FDA Product Code
- LON
- Regulation
- 21 CFR Part 866.1645
- Advisory Committee
- Microbiology
- FDA Decision
- APPR Approved
- PMA Supplement
- S006
Other devices from Abbott Laboratories
Questions
How does this automated antimicrobial susceptibility test system differ from manual testing methods in terms of speed and standardization?
This system is specifically designed for short-incubation microbiological analysis, allowing for faster results compared to traditional manual methods. By automating the process, it ensures standardized testing conditions, reducing variability and improving consistency in determining bacterial susceptibility to antimicrobial agents—critical for timely clinical decision-making.
Is the device itself single-use or reusable, and how are consumables handled?
The ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEM is a reusable medical device, meaning the core instrument can be used repeatedly. However, consumables and reagents are provided separately for each test, ensuring sterile conditions and preventing cross-contamination between samples. This design maintains hygiene while extending the lifespan of the primary equipment.
What clinical environments or laboratory settings is this system intended for, and what regulatory pathway does it follow?
This system is intended for use in clinical microbiology laboratories, where rapid and accurate antimicrobial susceptibility testing is essential. It follows the FDA Premarket Approval (PMA) pathway, authorized under PMA N50525, and is classified as a Class II device (regulation 866.1645). The approval reflects its compliance with microbiological standards and regulatory requirements for automated testing systems.
Are there any specific storage requirements or limitations for this device?
While the ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEM itself is reusable and not subject to size or MRI safety constraints in the provided data, proper storage of consumables and reagents is implied to be critical for maintaining sterility and performance. Laboratories should follow manufacturer guidelines for handling and storing these components to ensure accuracy and reliability of test results.