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Sensititre Haemophilus/Streptococcus Pneumoniae (HP) MIC Plate

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062722

by Trek Diagnostic Systems, Inc.

Identifiers

510(k) Number
K062722 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 Plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species. It is a multi-well plastic microtitre plate containing dried, stabilized antimicrobics used for quantitative susceptibility testing.

The device is supplied as a plate and is intended for laboratory use. It is a Class II device cleared by the FDA under 510(k) K062722. The plate is used for manual antimicrobial susceptibility testing in microbiology laboratories.

Frequently asked questions

What is the Sensititre HP MIC Plate used for?

The Sensititre HP MIC Plate is an in vitro diagnostic product used for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species in microbiology laboratories. It performs quantitative antimicrobial susceptibility testing.

How is the Sensititre HP MIC Plate supplied?

The device is supplied as a multi-well plastic microtitre plate containing dried, stabilized antimicrobics. It is intended for laboratory use and requires manual processing for antimicrobial susceptibility testing.

Is the Sensititre HP MIC Plate single-use or reusable?

The Sensititre HP MIC Plate is designed for single-use in clinical laboratory settings. Each plate contains dried antimicrobics and should not be reused or resterilized to ensure accurate test results.

What regulatory status does the Sensititre HP MIC Plate have?

The Sensititre HP MIC Plate is a Class II device cleared by the FDA under 510(k) K062722. It has been determined to be substantially equivalent to predicate devices for manual antimicrobial susceptibility testing 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 Haemophilus/Streptococcus Pneumoniae (Hp) Mic Plate (K062722 ..., Sensititre Haemophilus/Streptococcus Pneumoniae (Hp) Mic Plate, PDF Sensititre® 20-24 hour Haemophilus influenzae/ Streptococcus pneumoniae ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Trek Diagnostic Systems, Inc.

Sources (1)

  • FDA 510(k) K062722 24 fields · synced Sep 24, 2026