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510(k) Data Aggregation

    K Number
    K120900
    Device Name
    I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2013-05-31

    (431 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The i-STAT PT Control Level 1 (normal) and PT Control Level 2 (abnormal) are used for quality control of i-STAT PT cartridges on i-STAT handheld and wireless systems.
    The i-STAT ACT Control Level 1 (normal) and ACT Control Level 2 (abnormal) are used for quality control of i-STAT ACT cartridges on i-STAT handheld and wireless systems.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to CLINIQA CORPORATION regarding their i-STAT PT Control and i-STAT ACT Control devices. This type of document declares substantial equivalence to a legally marketed predicate device, primarily focusing on regulatory compliance and the device's intended use (quality control for other in vitro diagnostic devices). It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found for a novel diagnostic device's performance claims.

    Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory approval letter, not a performance study report.

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