Identity
- Trade Name
- SENSITITRE FDA PMA
- Generic Name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION FDA PMA
Identifiers
- PMA Number
- N50531 FDA PMA
- FDA Product Code
- LON FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.1645 FDA PMA
- Regulation Number
- 866.1645 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S005 FDA PMA
The Sensititre Automated Antimicrobial Susceptibility Test System is an automated microbiology device designed for determining the susceptibility of microorganisms to antimicrobial agents. Classified as a Class II device under FDA regulations, it adheres to standardized protocols for short-incubation antimicrobial testing, aiding in the identification of bacterial resistance patterns and guiding appropriate therapeutic interventions in clinical settings.
This system is intended for use in microbiology laboratories and operates as a reusable, non-sterile instrument. It requires specialized training for operation and is regulated under FDA Premarket Approval (PMA) with PMA number N50531. The device is supplied with consumables and software for automated reading and interpretation of antimicrobial susceptibility results, ensuring compliance with regulatory requirements for antimicrobial testing.
Frequently asked questions
What is the primary purpose of the Sensititre Automated Antimicrobial Susceptibility Test System in a clinical setting?
The Sensititre system is designed to determine the susceptibility of microorganisms to antimicrobial agents, helping laboratories identify bacterial resistance patterns. This aids clinicians in selecting the most effective therapeutic interventions by providing automated, standardized results for short-incubation antimicrobial testing.
Is the Sensititre device itself sterile, or are there sterile components involved in its use?
The Sensititre Automated Antimicrobial Susceptibility Test System is a reusable, non-sterile instrument. However, it is paired with consumables (such as antimicrobial panels or plates) that are intended for single-use and are likely sterile or prepared under controlled conditions to ensure accurate testing.
What type of training is required to operate the Sensititre system, and who should use it?
The Sensititre system requires specialized training for operation, as indicated in its description. It is intended for use in microbiology laboratories by trained personnel, such as microbiologists or laboratory technicians, who are familiar with antimicrobial susceptibility testing protocols.
How is the regulatory approval status of the Sensititre system defined, and what does this mean for users?
The Sensititre system holds FDA Premarket Approval (PMA) with the approval number N50531, meaning it has undergone rigorous review by the FDA to ensure safety and effectiveness. This classification as a Class II device also indicates it is subject to specific regulatory controls, including compliance with standardized antimicrobial testing protocols.
What types of antimicrobial susceptibility tests does the Sensititre system support, and how does it automate the process?
The Sensititre system supports short-incubation antimicrobial susceptibility testing, which helps quickly identify bacterial resistance patterns. It automates the reading and interpretation of results through integrated software, reducing manual labor and ensuring consistency with standardized protocols for clinical decision-making.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | N50531 | Class II | Active |
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Manufacturer
- Manufacturer
- Trek Diagnostic Systems, Inc.
Sources (1)
- FDA PMA N50531 23 fields · synced Sep 18, 2026