Sensititre 18-24 Hours Susceptibility Plates
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K024353 FDA 510(k)
- FDA Product Code
- LTT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1640 FDA 510(k)
- Regulation Number
- 866.1640 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sensititre 18–24 Hours Susceptibility Plates are antimicrobial susceptibility test panels designed for in vitro diagnostic use. These plates facilitate automated antimicrobial susceptibility testing of gram-negative and gram-positive organisms, enabling the determination of minimum inhibitory concentrations (MICs) or breakpoint susceptibility results. They are categorized under antimicrobial test panels and are intended for laboratory use in microbiology settings.
The plates are supplied as single-use, non-sterile items and are intended for use in clinical microbiology laboratories. They require no special storage conditions beyond standard laboratory practices and are compatible with automated reading systems like the Sensititre AutoReader. The device holds FDA 510(k) clearance under the Traditional review pathway, with the advisory committee classification under Microbiology. Multiple registration numbers and product codes (e.g., LTT) are associated with this device type, reflecting its regulatory classification as a Class II medical device.
Frequently asked questions
What are the Sensititre 18–24 Hours Susceptibility Plates used for?
These plates are designed for in vitro antimicrobial susceptibility testing in clinical microbiology labs. They help determine the minimum inhibitory concentrations (MICs) or breakpoint susceptibility results for gram-negative and gram-positive organisms, enabling accurate identification of bacterial resistance patterns to guide treatment decisions.
Are the Sensititre 18–24 Hours Susceptibility Plates single-use or reusable?
The plates are supplied as single-use items, meaning each plate is intended for one test cycle only. This ensures consistency and reduces the risk of cross-contamination in laboratory settings.
Do the Sensititre 18–24 Hours Susceptibility Plates require special storage conditions?
No special storage conditions are required beyond standard laboratory practices. They should be stored in a way that maintains their integrity until use, following typical microbiology lab protocols.
Are these plates compatible with automated reading systems?
Yes, the Sensititre 18–24 Hours Susceptibility Plates are designed to be compatible with automated reading systems like the Sensititre AutoReader, streamlining the testing process and improving efficiency in clinical microbiology labs.
What regulatory pathway was followed for the FDA clearance of these plates?
The Sensititre 18–24 Hours Susceptibility Plates received FDA 510(k) clearance under the Traditional review pathway, with the advisory committee classification under Microbiology. This classification reflects their use in antimicrobial susceptibility testing for bacterial organisms.
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. Sources consulted: Sensititre 18-24 Hours Susceptibility Plates, K031545 FDA 510(k) - SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE, Sensititre 18-24 Hours Susceptibility Plates, SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES by TREK DIAGNOSTIC ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K024353 | Class II | Active |
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Manufacturer
- Manufacturer
- Trek Diagnostic Systems, Inc.
Sources (1)
- FDA 510(k) K024353 24 fields · synced Oct 1, 2026