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Mueller Hinton Agar W/Blood & Cofactor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K841138

by Anaerobe Systems

Identifiers

510(k) Number
K841138 FDA 510(k)
FDA Product Code
JTZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1700 FDA 510(k)
Regulation Number
866.1700 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Mueller Hinton Agar with Blood and Cofactor is a culture medium classified under Culture Media for Antimicrobial Susceptibility Testing (FDA Product Code JTZ). It is designed for the cultivation and testing of microbial organisms, particularly in determining their susceptibility to antimicrobial agents. This medium provides a standardized base for reliable antimicrobial testing in microbiology laboratories.

The device is supplied as a ready-to-use agar medium, intended for single-use in clinical microbiology settings. It is regulated under FDA 510(k) clearance (K841138) and falls under Device Class II (FDA regulation 866.1700). Sterility and quality control are critical; users must follow the manufacturer’s instructions for proper handling, storage, and validation per CLIA or IQCP requirements. No MRI safety or reusable specifications are indicated.

Frequently asked questions

What is Mueller Hinton Agar with Blood and Cofactor primarily used for in clinical microbiology labs?

This medium is specifically designed for cultivating microbial organisms and conducting antimicrobial susceptibility testing. It provides a standardized base to reliably determine how bacteria respond to different antimicrobial agents, ensuring accurate results for infection treatment planning.

Is Mueller Hinton Agar with Blood and Cofactor intended for single-use or repeated use in a lab setting?

The device is explicitly labeled as a ready-to-use agar medium intended for single-use only. This ensures sterility and consistency in antimicrobial susceptibility testing, as reuse could compromise accuracy or introduce contamination risks.

How should this product be stored, and are there any special handling requirements?

While exact storage instructions are manufacturer-specific, the product’s single-use nature and critical role in microbiology demand adherence to sterility protocols. It should be stored according to the manufacturer’s guidelines (e.g., refrigeration if applicable) and validated per CLIA or IQCP requirements to maintain integrity before use.

What regulatory pathway does Mueller Hinton Agar with Blood and Cofactor follow, and what does that mean for buyers?

The device follows the FDA 510(k) clearance pathway (K841138) and is classified as Device Class II under FDA regulation 866.1700. This means it has undergone premarket review to demonstrate substantial equivalence to a predicate device, ensuring it meets established safety and effectiveness standards for antimicrobial susceptibility testing in microbiology.

Does this product require any special validation or quality control measures before use in a lab?

Yes, since this is a sterile culture medium for critical testing, labs must follow the manufacturer’s instructions for proper handling, storage, and validation. Compliance with CLIA (Clinical Laboratory Improvement Amendments) or IQCP (Internal Quality Control Program) requirements is essential to ensure reliable antimicrobial susceptibility results.

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: MUELLER HINTON AGAR W/BLOOD & COFACTOR - Innolitics, MUELLER HINTON AGAR W/BLOOD & COFACTOR 510(k) K841138 - fda.report, PDF MUELLER HINTON AGAR - Thermo Fisher Scientific

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Anaerobe Systems

Sources (1)

  • FDA 510(k) K841138 24 fields · synced Sep 19, 2026