Sensititre Haemophilus/Streptococcus Pneumoniae (HP) MIC and Susceptibility Plates
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K062841 FDA 510(k)
- FDA Product Code
- JWY 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 Haemophilus/Streptococcus Pneumoniae (HP) MIC and Susceptibility Plates are manual antimicrobial susceptibility test systems designed for in vitro diagnostic use. These plates are intended for determining the minimum inhibitory concentration (MIC) of antimicrobial agents against Haemophilus influenzae and Streptococcus pneumoniae isolates, aiding in the selection of appropriate antibiotic therapy. The system adheres to microbiological standards for accurate susceptibility testing, ensuring reliable clinical decision-making.
These plates are supplied in sterile, single-use format and are intended for use in clinical microbiology laboratories. They are classified as Class II medical devices under FDA regulations and have received 510(k) clearance for antimicrobial susceptibility testing. Storage and handling follow standard aseptic techniques to maintain sterility, and the plates are available in specified pack sizes as indicated in the product code (JWY). Compliance with regulatory requirements ensures their suitability for routine diagnostic use in microbiology settings.
Frequently asked questions
What types of bacterial infections can these plates help identify antibiotic resistance for?
These Sensititre Haemophilus/Streptococcus Pneumoniae (HP) MIC and Susceptibility Plates are specifically designed to test *Haemophilus influenzae* and *Streptococcus pneumoniae* isolates. They determine the minimum inhibitory concentration (MIC) of antimicrobial agents against these bacteria, helping clinicians select the most effective antibiotic therapy for infections caused by these pathogens.
Are these plates meant for single-use or can they be reused after opening?
The plates are supplied in a sterile, single-use format, meaning each package is intended for one test session only. Reusing them would compromise sterility and potentially introduce contamination, which could invalidate test results. Always follow standard aseptic techniques when handling to maintain integrity.
How should these plates be stored to ensure they remain effective?
Storage follows standard aseptic techniques to preserve sterility. While the exact storage conditions aren’t detailed in the data, most antimicrobial susceptibility plates require protection from light, moisture, and extreme temperatures. Check the packaging instructions for the manufacturer’s recommended storage environment (typically room temperature, dry conditions). Avoid refrigeration unless specified.
What is the product code for these plates, and does it indicate any specific pack sizes?
The product code for these plates is JWY, which is associated with the Sensititre HP system. The exact pack sizes aren’t detailed in the provided data, but the product code helps identify the correct version for ordering. For precise pack quantities, refer to the manufacturer’s catalog or technical documentation.
How were these plates determined to be suitable for clinical use?
These plates received FDA 510(k) clearance under the Traditional review pathway, classified as a Class II medical device. The clearance was based on a determination of substantial equivalence to a predicate device, meaning they meet established microbiological standards for antimicrobial susceptibility testing. This ensures their reliability for clinical decision-making in microbiology laboratories.
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™ HPB1 10/Pk. | Request for Quote | Thermo Scientific ..., PDF Sensititre® 20-24 hour Haemophilus influenzae/ Streptococcus pneumoniae ..., Thermo Scientific Sensititre HPB1 10/Pk. | Buy Online | Thermo ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062841 | Class II | Active |
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Manufacturer
- Manufacturer
- Trek Diagnostic Systems, Inc.
Sources (1)
- FDA 510(k) K062841 24 fields · synced Sep 20, 2026