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Sensititre Haemophilus/Streptococcus Pneumoniae (HP) MIC Plate

FDA 510(k)

Class II (US FDA 510(k))

510(k) K013075

by Trek Diagnostic Systems, Inc.

Identifiers

510(k) Number
K013075 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 a manual antimicrobial susceptibility test system used for in vitro diagnostic testing. It is designed to determine the minimum inhibitory concentration (MIC) of antimicrobial agents against Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species isolates.

This device is supplied as a multi-well plastic microtitre plate containing dried, stabilized antimicrobials. It is intended for use in clinical laboratories and is authorized under FDA 510(k) clearance K013075. The plate is used for quantitative susceptibility testing and is not indicated as sterile, single-use, or reusable in the provided data.

Frequently asked questions

What is the Sensititre Haemophilus/Streptococcus Pneumoniae HP MIC Plate used for?

It is used for in vitro diagnostic testing to determine the minimum inhibitory concentration (MIC) of antimicrobial agents against Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species isolates, supporting quantitative susceptibility testing in clinical laboratories.

How is the Sensititre Haemophilus/Streptococcus Pneumoniae HP MIC Plate supplied and stored?

It is supplied as a multi-well plastic microtitre plate containing dried, stabilized antimicrobials and is intended for use in clinical laboratories; however, the provided data does not specify storage conditions or whether it is sterile, single-use, or reusable.

What regulatory authorization does the Sensititre Haemophilus/Streptococcus Pneumoniae HP MIC Plate have?

It is authorized under FDA 510(k) clearance K013075, with a decision date of November 26, 2001, and is classified as substantially equivalent to a legally marketed predicate device under product code JWY.

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, Sensititre Haemophilus/Streptococcus Pneumoniae (Hp) Mic Plate (K062722 ..., 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) K013075 24 fields · synced Sep 21, 2026