Heamophilus/Streptococcus Pneumoniae
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K012895 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)
This device is a Manual Antimicrobial Susceptibility Test System for in vitro diagnostic use, designed to determine the minimum inhibitory concentration (MIC) of antimicrobial agents against Haemophilus influenzae and Streptococcus pneumoniae. It falls under the classification of microbiological test systems and aids in identifying bacterial susceptibility patterns to guide therapeutic decisions in clinical infections, including respiratory tract and ear infections.
The Haemophilus/Streptococcus Pneumoniae MIC Plate is supplied as a sterile, single-use diagnostic tool for laboratory use. It is intended for use in clinical microbiology settings and adheres to regulatory standards as a Class 2 device under FDA 510(k) clearance (K012895). The product is manufactured by Trek Diagnostic Systems, Inc., and requires proper storage and handling as specified in accompanying documentation to ensure accuracy and reliability of antimicrobial susceptibility testing results.
Frequently asked questions
What is the Trek Haemophilus/Streptococcus Pneumoniae MIC Plate used for?
This device measures the minimum inhibitory concentration (MIC) of antimicrobial agents against *Haemophilus influenzae* and *Streptococcus pneumoniae*. By identifying bacterial susceptibility patterns, it helps clinicians select effective treatments for infections like respiratory tract and ear infections, ensuring targeted therapy based on laboratory results.
How is the Haemophilus/Streptococcus Pneumoniae MIC Plate supplied and prepared for use?
The plate is supplied as a sterile, single-use diagnostic tool designed exclusively for in vitro testing in clinical microbiology laboratories. It requires no additional preparation beyond following the manufacturer’s instructions for inoculation and incubation, ensuring accurate susceptibility testing without cross-contamination risks.
Is the MIC Plate reusable, or is it intended for single-use only?
The device is explicitly designed for single-use only. This design minimizes contamination risks and ensures consistent, reliable results for each test. Reusing the plate could compromise sterility and accuracy, which is critical for antimicrobial susceptibility testing.
What storage conditions are required for the Haemophilus/Streptococcus Pneumoniae MIC Plate?
Proper storage is essential to maintain the plate’s integrity and performance. The accompanying documentation specifies storage requirements, typically including protection from extreme temperatures, moisture, and direct light. Adhering to these guidelines prevents degradation of the antimicrobial agents and ensures valid test results when used.
Does this device require any specific regulatory approvals for use in clinical settings?
The Haemophilus/Streptococcus Pneumoniae MIC Plate holds FDA 510(k) clearance (K012895) as a Class 2 medical device, confirming its compliance with U.S. regulatory standards for antimicrobial susceptibility testing. Clinicians should verify local regulatory requirements, but this clearance ensures the device meets established safety and effectiveness criteria for its intended use.
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: Haemophilus Streptococcus Pneumoniae - Trek Diagnostic Systems | FDA ..., Heamophilus Streptococcus Pneumoniae - Trek Diagnostic Systems | FDA ..., HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE 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 | K012895 | Class II | Active |
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Manufacturer
- Manufacturer
- Trek Diagnostic Systems, Inc.
Sources (1)
- FDA 510(k) K012895 24 fields · synced Oct 1, 2026