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510(k) Data Aggregation

    K Number
    K252680
    Manufacturer
    Date Cleared
    2025-09-24

    (30 days)

    Product Code
    Regulation Number
    880.2800
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Celerity™ 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

    • Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems.
    • STERRAD® 100S Sterilizer (Default Cycle)
    • Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear
    • Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear® Technology

    When used in conjunction with the Celerity™ HP Incubator or the Celerity™ Incubator, the Celerity™ 20 HP BI provides a fluorescent result within 20 minutes.

    Device Description

    The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, STERIS Celerity™ Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

    AI/ML Overview

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