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510(k) Data Aggregation

    K Number
    K111414
    Device Name
    QUANTA FLASH (TM) DGP SCREEN
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2011-10-20

    (153 days)

    Product Code
    MST,JIX,JJX
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology (IM)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUANTA FLASH (TM) DGP SCREEN

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

    The QUANTA Flash™ DGP Screen is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG and IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum on the BIO-FLASH® instrument. It is an aid in the diagnosis of celiac disease and dermatitis herpetiformis in conjunction with clinical findings and other laboratory tests.

    The QUANTA Flash™ DGP Screen Calibrators are intended for use with the QUANTA Flash™ DGP Screen chemiluminescent immunoassay (CIA) kit run on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgG and IgA anti-DGP antibodies in serum.

    The QUANTA Flash™ DGP Screen Controls are intended for quality control purposes of the QUANTA Flash™ DGP Screen chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a diagnostic device, not a study report that details acceptance criteria and performance data in the structured format requested. Therefore, I cannot extract most of the requested information directly from this document.

    However, I can provide the following based on the information available:

    1. Device Name: QUANTA Flash™ DGP Screen, QUANTA Flash™ DGP Screen Calibrators, QUANTA Flash™ DGP Screen Controls
    2. Indications For Use: The QUANTA Flash™ DGP Screen is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG and IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum on the BIO-FLASH® instrument. It is an aid in the diagnosis of celiac disease and dermatitis herpetiformis in conjunction with clinical findings and other laboratory tests.

    The document does not contain the following information:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for the test set.
    • Data provenance (country of origin, retrospective/prospective).
    • Number of experts used to establish ground truth.
    • Qualifications of experts.
    • Adjudication method.
    • Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Effect size of human reader improvement with AI assistance.
    • Results of a standalone (algorithm only) performance study.
    • Type of ground truth used (expert consensus, pathology, outcomes data).
    • Sample size for the training set.
    • How ground truth for the training set was established.

    This document is primarily for regulatory clearance and states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not detail the specific studies and performance metrics used to make that determination. Such details would typically be found in the actual 510(k) submission summary or a separate clinical study report, neither of which is included in this extract.

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