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510(k) Data Aggregation

    K Number
    K132082
    Device Name
    AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
    Manufacturer
    AESKU.DIAGNOSTICS
    Date Cleared
    2013-12-05

    (153 days)

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

    AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK

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

    AESKULISA DGP-Check is an in-vitro diagnostic device. This solid phase enzyme immunassay employs synthetic, deemicated gliadin-derived pertides for the combined seniqualitative detation of 194 and 195 and 195 and 195 and its deamical desirical d Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diac disease (gluter-sensitive enteropatiy) and should be used in conjunction with ather serological tests and clinical findings.

    AESKULISA DGP-G is an in-vitro diagnostic device This salid phase enzyme immuncessay employs synthetic, deamicated gliadin-derived peptides for the semiquantitative and qualitative detection of IgG antibodies against deamidded Gliadin-specific peptides (DGP) in human serum. The assy is an aid in the diegnosis of celies disease (gluter-sensitive enteropedly) and should be used in conjunction with other serological tests and clinical findings.

    AESKULISA DGP-A is an in-vitro diagnostic device. This solid phase enzyme immunossay employs synthetic, deamidated gliadin-derived peptides for the semiqualitative and qualitative detection of 1gA antibodies against deaminded Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diagnosis of cellac disease (gluter-sensitive enteropathy) and should be used in corjunction with other serological tests and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided document does not contain the detailed study information required to fill out the table and answer your questions. The text includes an FDA 510(k) clearance letter for the AESKULISA DGP-A, AESKULISA DGP-G, and AESKULISA DGP-Check devices, which are in-vitro diagnostic devices for celiac disease.

    While it states the indications for use and classification, it does not provide:

    • Details of any specific study (e.g., design, methodology, results) that proves the device meets acceptance criteria.
    • Acceptance criteria themselves, or reported device performance metrics like sensitivity, specificity, accuracy, etc.
    • Information on sample sizes for test or training sets, data provenance, ground truth establishment, expert involvement, or any multi-reader multi-case studies.

    Therefore, I cannot fulfill your request based on the given information.

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