← Back to catalogue

Sensititre Haemophilus/Streptococcus Pneumoniae (HP) MIC Susceptibility Plates

FDA 510(k)

Class II (US FDA 510(k))

510(k) K013925

by Trek Diagnostic Systems, Inc.

Identifiers

510(k) Number
K013925 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 Susceptibility Plates are manual antimicrobial susceptibility test systems designed for in vitro diagnostic use. These multi-well plastic microtitre plates contain dried, stabilized agents to perform clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species.

This device is supplied as a 10-pack and is intended for clinical laboratory use. It has received FDA 510(k) clearance for its intended application. Users should refer to the product documentation for specific storage requirements and handling instructions.

Frequently asked questions

What are the Sensititre HP MIC Susceptibility Plates used for?

These plates are manual antimicrobial susceptibility test systems designed for in vitro diagnostic use. They are specifically intended for clinical laboratory testing of Haemophilus influenzae, Streptococcus pneumoniae, and other Streptococcus species.

How is this product supplied?

The Sensititre HP MIC Susceptibility Plates are supplied as a 10-pack of multi-well plastic microtitre plates. These plates contain dried, stabilized antimicrobial agents ready for clinical laboratory use.

What is the regulatory status of this device?

The Sensititre HP MIC Susceptibility Plates have received FDA 510(k) clearance for their intended application as a manual antimicrobial susceptibility test system. This indicates the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

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 ..., Sensititre Haemophilus/Streptococcus Pneumoniae (Hp) Mic Plate (K062722 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Trek Diagnostic Systems, Inc.

Sources (1)

  • FDA 510(k) K013925 24 fields · synced Oct 6, 2026