Improved Thayer Martin (Plate)
by Granite Diagnostics, Inc. 510(k)
Active
510(k) K770874
Overview
The Improved Thayer-Martin Plate is a selective culture medium designed for the isolation of pathogenic Neisseria species, including Neisseria gonorrhoeae and Neisseria meningitidis. It incorporates antimicrobial agents to suppress competing bacteria, enabling the selective growth of fastidious Neisseria organisms while maintaining optimal conditions for their identification. This plate is classified under Culture Media, For Isolation Of Pathogenic Neisseria (OpenFDA: JTY) and is intended for microbiological laboratory use in diagnostic settings.
The device is supplied as a single-use, non-sterile plate and requires sterilization prior to use, typically via autoclaving. It is intended for use in clinical microbiology laboratories and adheres to regulatory standards under FDA 510(k) clearance (K770874). The plate is available in standard sizes as defined by the product code JTY and must be stored in a dry, cool environment to preserve its integrity. No MRI safety considerations apply, as it is not intended for use in magnetic resonance environments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770874 | Date8 Jun 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JTY
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.2410
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Granite Diagnostics, Inc.
Questions
What is the Improved Thayer-Martin Plate used for?
The Improved Thayer-Martin Plate is a selective culture medium specifically designed to isolate pathogenic *Neisseria* species, including *Neisseria gonorrhoeae* and *Neisseria meningitidis*. It contains antimicrobial agents that inhibit competing bacteria, allowing only fastidious *Neisseria* organisms to grow while maintaining optimal conditions for their identification. This makes it essential for diagnostic microbiology labs testing for sexually transmitted infections or meningitis.
How is the Improved Thayer-Martin Plate supplied and prepared for use?
The plate is supplied as a single-use, non-sterile item. Before use, it must be sterilized via autoclaving to ensure a sterile environment for culturing. This step is critical to prevent contamination and ensure accurate diagnostic results. Always follow standard microbiological sterilization protocols when preparing the plate.
Is the Improved Thayer-Martin Plate sterile when received?
No, the Improved Thayer-Martin Plate is intentionally supplied in a non-sterile state. Sterilization is required prior to use, typically achieved through autoclaving. This design aligns with standard practices for culture media, where sterility is achieved at the point of use rather than during manufacturing.
What storage conditions are recommended for the Improved Thayer-Martin Plate?
The plate should be stored in a dry, cool environment to maintain its integrity and effectiveness. Exposure to moisture or extreme temperatures could compromise the antimicrobial agents and selective properties of the medium, potentially leading to inaccurate or unreliable culture results. Always check the packaging for any additional storage instructions.
What sizes are available for the Improved Thayer-Martin Plate?
The Improved Thayer-Martin Plate is available in standard sizes as defined by the product code JTY, which is the classification for Culture Media for Isolation of Pathogenic *Neisseria*. While specific dimensions are not detailed in the data, this product code ensures consistency with widely recognized industry standards for such diagnostic plates.