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510(k) Data Aggregation

    K Number
    K990720
    Device Name
    SAS HCG SERUM CONTROLS
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1999-03-19

    (14 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SASTM hCG Serum Controls are intended to be used to monitor the performance and accuracy of SASTM pregnancy test kits. These controls are for professional use only.

    Device Description

    SAS™ hCG Serum Controls

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a device named "SAS™ hCG Serum Controls." It primarily addresses regulatory approval and provides a brief "Indications For Use" statement.

    Based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This document is a regulatory approval notice, not a study report.

    Therefore, I cannot provide a table or answer the specific questions about the study design and results. The document only confirms the device's intended use:

    Indications For Use:
    SASTM hCG Serum Controls are intended to be used to monitor the performance and accuracy of SASTM pregnancy test kits. These controls are for professional use only.

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