Haemophilus/Streptococcus Pneumoniae (HP) MIC Plate
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K013368 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)
This device is a panel test for antimicrobial susceptibility, specifically designed for Haemophilus and Streptococcus pneumoniae. It is used to determine the minimum inhibitory concentration (MIC) of antibiotics against these bacterial pathogens.
The device is supplied as a diagnostic panel for use in microbiology laboratories. It is a traditional 510(k) cleared device with product code LTT and regulation number 866.1640, intended for antimicrobial susceptibility testing in accordance with its cleared indications.
Frequently asked questions
What is the HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC Plate used for?
This device is used to determine the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus and Streptococcus pneumoniae bacterial pathogens in microbiology laboratories. It supports antimicrobial susceptibility testing to guide appropriate antibiotic selection for infections caused by these organisms.
How is the HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC Plate supplied and intended for use?
The device is supplied as a diagnostic panel for use in microbiology laboratories. It is designed for laboratory professionals to perform antimicrobial susceptibility testing by measuring the lowest concentration of an antibiotic that inhibits visible growth of the target bacteria.
What regulatory pathway and product code apply to the HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC Plate?
This device was cleared through the traditional 510(k) pathway under product code LTT and regulation number 866.1640. It was found substantially equivalent to a predicate device, with clearance granted on November 20, 2001, under K013368.
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_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013368 | Class II | Active |
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Manufacturer
- Manufacturer
- Trek Diagnostic Systems, Inc.
Sources (1)
- FDA 510(k) K013368 24 fields · synced Sep 23, 2026