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510(k) Data Aggregation

    K Number
    K172461
    Device Name
    AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
    Manufacturer
    Aesku.Diagnostics GmbH & Co. KG
    Date Cleared
    2018-03-23

    (221 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aesku.Diagnostics GmbH & Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
    Device Description
    AESKUSLIDES ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in coniunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. Slides coated with human neutrophil granulocytes for autoantibody detection are fixated by two different methods: ethanol (EtOH) fixation or formalin fixation. Ethanol fixation allows cell components to move through the cells after the fixation process. Formalin fixation causes cellular components to cross-link (a movement of cellular components is abrogated and the patterns are distinct). By processing serum on both Ethanol and Formalin-fixed slides, the user can confirm if the pattern is C-, P-, or A-ANCA, according to the table below.
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESKU.DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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    K Number
    K091859
    Device Name
    AESKU PR3
    Manufacturer
    AESKU.DIAGNOSTICS
    Date Cleared
    2010-06-03

    (349 days)

    Product Code
    MOB, TRA
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESKU.DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AESKULISA PR3 is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the semiquantitative and qualitative detection of antibodies against proteinase 3 in human serum. The assay is an aid in the diagnosis of Wegener's granulomatosis and should be used in conjunction with other serological tests and clinical findings.
    Device Description
    solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes
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    K Number
    K091860
    Device Name
    AESKULISA MPO, MODEL 30-7303US
    Manufacturer
    AESKU.DIAGNOSTICS
    Date Cleared
    2010-02-23

    (249 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESKU.DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AESKULISA MPO is a solid phase enzyme immunoassay employing purified native myeloperoxidase (MPO) from human peripheral blood polymorphonuclear cells for the semiquantitative and qualitative detection of antibodies against MPO in human serum. The assay is an aid in the diagnosis of autoimmune systemic vasculitis such as microscopic polyangiitis, and glomerulonephritis and should be used in conjunction with other laboratory and clinical findings.
    Device Description
    AESKULISA MPO is a solid phase enzyme immunoassay.
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    K Number
    K081251
    Device Name
    MODIFICATION TO AESKULISA DS DNA G
    Manufacturer
    AESKU.DIAGNOSTICS
    Date Cleared
    2008-05-13

    (11 days)

    Product Code
    LSW
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESKU.DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AESKULISA®dsDNA-G is a solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. The assay is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
    Device Description
    solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum.
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    K Number
    K081104
    Device Name
    AESKULISA ANA HEP-2, REF 30-7115US
    Manufacturer
    AESKU.DIAGNOSTICS
    Date Cleared
    2008-05-02

    (14 days)

    Product Code
    LKJ
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESKU.DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG artibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and spectic antigens. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT). The assay is a tool in the diagnosis of certain systemic theumatic diseases and should be used in conjunction with other serological tests and clinical findings.
    Device Description
    AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG artibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and spectic antigens.
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    K Number
    K052439
    Device Name
    AESKULISA GLIA A AND AESKULISA GLIA G
    Manufacturer
    AESKU.DIAGNOSTICS
    Date Cleared
    2006-02-07

    (154 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESKU.DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AESKULISA Glia-A is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of IgA antibodies against Gliadin in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjuction with other serological tests and clinical findings. The AESKULISA Glia-G is a solid phase enzyme immunoassay for the semiquantitative and qualitative detection of IgG antibodies against Gliadin in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjuction with other serological tests and clinical findings.
    Device Description
    solid phase enzyme immunoassay
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    K Number
    K041628
    Device Name
    AESKULISA DS DNA G
    Manufacturer
    AESKU.DIAGNOSTICS
    Date Cleared
    2004-10-14

    (120 days)

    Product Code
    LSW
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESKU.DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AESKULISA dsDNA-G is a solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. The assay is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
    Device Description
    AESKULISA dsDNA-G is a solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum.
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    K Number
    K041753
    Device Name
    AESKULISA ENA 6 S
    Manufacturer
    AESKU.DIAGNOSTICS
    Date Cleared
    2004-07-14

    (15 days)

    Product Code
    LLL
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESKU.DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AESKULISA ENA 6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the diagnosis of certain systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.
    Device Description
    solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and purified native human snRNP/Sm, Sm and SS-A 60 kDa.
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