Autobac MTS Plus Test System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Autobac Mts Plus Test Sytem

Generic Name

SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

PMA Number

P810024 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

APPR Approved

PMA Supplement

S002

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• What is the Autobac MTS Plus Test System used for in a clinical setting?

  The Autobac MTS Plus Test System is designed for automated antimicrobial susceptibility testing in microbiology laboratories. It helps determine how effective different antimicrobial agents are against bacterial isolates, enabling faster identification of bacterial resistance patterns through shorter incubation times compared to traditional methods.

• Is the Autobac MTS Plus Test System reusable or single-use?

  The Autobac MTS Plus Test System is supplied as a reusable device. The provided data does not specify any single-use or sterile requirements, indicating it is intended for repeated use in clinical microbiology settings.

• What regulatory pathway was followed for FDA approval of the Autobac MTS Plus Test System?

  The Autobac MTS Plus Test System received FDA Premarket Approval (PMA) under the PMA number P810024. This approval was granted following a review by the FDA’s Microbiology (MI) advisory committee, with the decision finalized on March 4, 1982, and published in the Federal Register on March 26, 1982.

• What classification does the Autobac MTS Plus Test System fall under in the FDA’s regulatory framework?

  The Autobac MTS Plus Test System is classified as a Class II medical device under FDA regulation 866.1645. This classification is associated with devices that generally present moderate risk and require special controls to ensure safety and effectiveness.

• Are there any specific storage requirements mentioned for the Autobac MTS Plus Test System?

  The provided data does not include explicit storage instructions for the Autobac MTS Plus Test System. However, as a reusable device, proper maintenance and storage conditions should be followed to ensure its functionality and longevity, though these details would typically be outlined in the manufacturer’s instructions for use.