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510(k) Data Aggregation

    K Number
    K993715
    Device Name
    QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3
    Manufacturer
    SERACARE TECHNOLOGY
    Date Cleared
    1999-11-16

    (13 days)

    Product Code
    JJT
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3

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

    QUALITROL CARDIAC MARKER CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze for indicators of possible cardiac abnormalities.

    Device Description

    liquid human serum based assayed quality control material

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called "QUALITROL Cardiac Marker Control, Level 1, 2 and 3". This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

    However, this document does not contain the detailed information necessary to describe acceptance criteria and a study proving the device meets those criteria. The 510(k) clearance process focuses on substantial equivalence to a legally marketed predicate device, rather than requiring a detailed clinical study demonstrating device performance against specific acceptance criteria.

    The letter mentions the "Indications for Use Statement," which describes what the device is intended to do: "QUALITROL CARDIAC MARKER CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze for indicators of possible cardiac abnormalities." This statement defines the purpose of the device, but not its performance acceptance criteria.

    Therefore, I cannot provide the requested information based solely on the content of this document. A 510(k) submission typically includes data to support substantial equivalence (e.g., analytical performance studies for in-vitro diagnostic devices), but those specific details are not present in this regulatory clearance letter.

    To fully answer your request regarding acceptance criteria and a study proving device performance, I would need access to the actual 510(k) submission data (e.g., the analytical studies like precision, accuracy, stability, etc., that would have been submitted to demonstrate the quality control material itself performs as expected).

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