MS 2 Automated System
by Abbott Laboratories PMA
Withdrawn
PMA N60242
Overview
The MS 2 Automated System is a Susceptibility Test Discs, Antimicrobial device, classified under FDA’s Class II regulatory category. It is designed for automated antimicrobial susceptibility testing in microbiology, enabling precise determination of bacterial resistance or sensitivity to antimicrobial agents through standardized disc diffusion methods.
This system is intended for use in clinical microbiology laboratories and operates as a reusable, non-sterile instrument. It requires no special storage conditions but must be maintained according to manufacturer guidelines. Authorized under FDA PMA (N60242), it adheres to regulatory requirements outlined in 21 CFR 866.1620 for antimicrobial susceptibility testing devices.
Regulatory status
Withdrawn since 4 May 1979. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberN60242 | Date4 May 1979 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Specification
- Generic Name
- Susceptibility test discs, antimicrobial
- PMA Number
- FDA Product Code
- JTN
- Regulation
- 21 CFR Part 866.1620
- Advisory Committee
- Microbiology
- FDA Decision
- APWD Approval withdrawn
Other devices from Abbott Laboratories
Questions
What is the primary purpose of the MS 2 Automated System in a clinical microbiology lab?
The MS 2 Automated System is specifically designed for automated antimicrobial susceptibility testing, which helps determine whether bacteria are resistant or sensitive to various antimicrobial agents. This is achieved through standardized disc diffusion methods, allowing labs to efficiently assess bacterial responses to treatments.
Is the MS 2 Automated System reusable or single-use, and what are the storage requirements?
The MS 2 Automated System is a reusable instrument, meaning it is not intended for single-use. It does not require special storage conditions, but it must be maintained according to the manufacturer’s guidelines to ensure proper functionality and reliability.
What regulatory pathway was followed for the approval of the MS 2 Automated System?
The MS 2 Automated System was authorized through the FDA’s Premarket Approval (PMA) process, with the approval number N60242. This pathway is typically used for higher-risk medical devices, ensuring the system meets stringent regulatory standards for antimicrobial susceptibility testing.
What type of antimicrobial testing does the MS 2 Automated System support, and in what setting is it intended for use?
The system supports standardized disc diffusion methods for antimicrobial susceptibility testing, which helps evaluate bacterial resistance or sensitivity to antimicrobial agents. It is intended exclusively for use in clinical microbiology laboratories, where precise and automated testing is required.