MDT Castle Biosign Test Pack

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K922212 ↗

FDA Product Code

FRC

Device Class

Class II

Regulation

21 CFR Part 880.2800

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Mdt Corp., Inc. →

• What is the MDT Castle Biosign Test Pack used for?

  The MDT Castle Biosign Test Pack is a Biological Sterilization Process Indicator designed to verify the effectiveness of sterilization processes, particularly in general hospital settings. It confirms whether microbial contamination is present or absent in sterilized loads, ensuring that the sterilization cycle achieved biological lethality. This helps validate that the sterilization process meets required standards for safety and efficacy.

• Is the MDT Castle Biosign Test Pack single-use or reusable?

  The MDT Castle Biosign Test Pack is intended for single-use only. Each pack is designed to be used once in a sterilization cycle, ensuring accurate and reliable results for biological monitoring. Reusing the device could compromise its integrity and the validity of the sterilization process verification.

• How should the MDT Castle Biosign Test Pack be stored before use?

  The device should be stored according to the manufacturer’s guidelines to maintain sterility and integrity prior to use. Proper storage typically involves keeping the pack in a clean, dry environment, protected from physical damage, moisture, and extreme temperatures. Always follow the instructions provided by MDT Corp., Inc., to ensure the device remains effective when used.

• Can the MDT Castle Biosign Test Pack be used in MRI environments?

  No, the MDT Castle Biosign Test Pack is not MRI-safe. It should only be used in non-MRI environments and handled in accordance with standard sterilization protocols. If MRI compatibility is required, alternative indicators should be selected.

• What regulatory approval does the MDT Castle Biosign Test Pack hold?

  The MDT Castle Biosign Test Pack is regulated under FDA 510(k) clearance with the clearance number K922212. This classification confirms that the device is substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for biological indicators in sterilization processes.