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Thayer Martin Agar

FDA 510(k)

Class II (US FDA 510(k))

510(k) K864253

by Mds Laboratories, Inc.

Identifiers

510(k) Number
K864253 FDA 510(k)
FDA Product Code
JTY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.2410 FDA 510(k)
Regulation Number
866.2410 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Thayer-Martin Agar is a selective culture medium classified under Culture Media, For Isolation Of Pathogenic Neisseria (Product Code: JTY). It is designed to support the growth of pathogenic Neisseria species, including Neisseria gonorrhoeae and Neisseria meningitidis, while inhibiting the proliferation of competing microorganisms. The medium incorporates antibiotics and enriched nutrients to create optimal conditions for selective isolation. Its formulation aligns with microbiological standards for diagnostic testing in clinical settings.

This product is supplied as a dehydrated powder for laboratory preparation, requiring reconstitution with sterile distilled water to create a solid agar plate. It is intended for single-use in microbiological laboratories under aseptic conditions. The device is regulated under FDA 510(k) clearance (K864253) and falls under Class II medical device classification (Regulation Number: 866.2410). Storage conditions typically include protection from light and moisture, with shelf-life details specified on the packaging.

Frequently asked questions

What is Thayer-Martin Agar specifically used for in a clinical microbiology lab?

Thayer-Martin Agar is a selective culture medium designed to isolate and grow pathogenic *Neisseria* species, such as *Neisseria gonorrhoeae* (the cause of gonorrhea) and *Neisseria meningitidis* (the cause of meningococcal infections). Its formulation includes antibiotics and enriched nutrients to suppress competing bacteria, ensuring accurate diagnostic testing for these specific pathogens.

How is Thayer-Martin Agar supplied and prepared for use?

Thayer-Martin Agar is supplied as a dehydrated powder that must be reconstituted with sterile distilled water to create a solid agar plate. It is intended for single-use in microbiology labs under aseptic conditions, meaning each batch is prepared fresh for one diagnostic test to maintain sterility and reliability.

What storage conditions are required for Thayer-Martin Agar, and how long can it be stored?

The product should be stored protected from light and moisture. The exact shelf-life is detailed on the packaging, but since it is a dehydrated powder, it is typically stable for an extended period when stored properly, provided it remains unopened and uncontaminated.

Is Thayer-Martin Agar reusable, or is it designed for single-use only?

Thayer-Martin Agar is explicitly designed for single-use in microbiological laboratories. After reconstitution and use, the agar plate is discarded to prevent contamination and ensure accurate diagnostic results, as reuse could compromise sterility and the integrity of the culture medium.

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: THAYER MARTIN AGAR (K864253) — FDA 510 (k) | Innolitics, THAYER MARTIN AGAR 510 (k) K864253 - FDA.report, Thayer-Martin agar - Wikipedia, PDF Thayer Martin Agar (Modified) - Thermo Fisher Scientific

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mds Laboratories, Inc.

Sources (1)

  • FDA 510(k) K864253 24 fields · synced Sep 20, 2026