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510(k) Data Aggregation

    K Number
    K182353
    Device Name
    EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
    Manufacturer
    Phadia AB
    Date Cleared
    2018-11-27

    (90 days)

    Product Code
    LJM, LKO
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000.
    Device Description
    The method-specific reagents are identical with K082759 (EliA CENP and EliA U1RNP) and K083117 (EliA RNP70), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells: - EliA CENP Wells are coated with human recombinant centromere protein B 2 carriers (12 wells each), ready to use; - -EliA U1RNP Wells are coated with human recombinant RNP (RNP70, A. C) proteins- 4 carriers (12 wells each), ready to use; - -EliA RNP70 Wells are coated with human recombinant RNP (70 kDa) protein-4 carriers (12 wells each), ready to use; EliA Sample Diluent: - -EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use: EliA IgG reagents: - EliA IgG Coniugate 50 or 200: ß-Galactosidase labeled anti-laG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide -6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use - EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 singleuse vials per strip, 0.3 mL each, ready to use; - EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use; - EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies 4 carriers (12 wells each), ready to use. The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages are required to carry out EliA CENP, EliA U1RNP and EliA RNP70 tests.
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    K Number
    K151559
    Device Name
    ImmuLisa Enhanced Centromere Antibody ELISA
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2016-03-11

    (275 days)

    Product Code
    LJM, ANT
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-centromere IgG antibodies in human serum as an aid in diagnosis of limited cutanteous systemic sclerosis / CREST in conjunction with other laboratory and clinical findings.
    Device Description
    An enzyme linked immunoassay (EUSA) for the qualitative detection of anti-centromere IgG antibodies in human serum as an aid in diagnosis of limited cutaneous systemic sclerosis / CREST in conjunction with other laboratory and clinical findings. This test is performed as a solid phase immunoassay. Microwells are coated with recombinant purified CENP-A centromere antigens. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the serum to bind to the centromere antibodies are detected by adding an enzyme labeled anti-human lgG conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.
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    K Number
    K140493
    Device Name
    ELIA SCL-70S IMMUNOASSAY
    Manufacturer
    PHADIA GMBH
    Date Cleared
    2014-10-30

    (245 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EliA Scl-70s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA Scl-70s uses the EliA IgG method on the instrument Phadia 100. EliA Scl-70s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA Scl-70s uses the EliA IgG method on the instrument Phadia 250.
    Device Description
    The Phadia EliA immunodiagnostic system is automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages except the positive and negative controls are required to carry out an EliA Scl-70° test.
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    K Number
    K123880
    Device Name
    QUANTA FLASH CENTROMERE
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2014-02-07

    (417 days)

    Product Code
    LJM, JIX, JJX
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QUANTA Flash Centromere is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-centromere protein B autoantibodies in human serum. The presence of anti-centromere protein B autoantibodies is used as an aid in the diagnosis Systemic Sclerosis, in conjunction with clinical finding and other laboratory tests. QUANTA Flash Centromere Calibrators are intended for use with the QUANTA Flash Centromere Reagents for the determination of IgG anti-Centromere autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate the unit values. QUANTA Flash Centromere Controls are intended for use with the QUANTA Flash Centromere Reagents for quality control in the determination of IgG anti-centromere protein B autoantibodies in human serum.
    Device Description
    Not Found
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    K Number
    K131330
    Device Name
    GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
    Manufacturer
    GOLD STANDARD DIAGNOSTICS
    Date Cleared
    2014-01-28

    (265 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gold Standard Diagnostics Antibody (ANA) Screen ELISA Test Kit is a qualitative assay for the detection of ANAs in human serum. The assay collectively detects in one well ANAs against double stranded DNA (dsDNA), SSA (Ro60 and Ro52), SSB (La), Sm, Sm/RNP, Scl-70, Jo-1, Ribosomal P, and Centromeric antibodies along with sera positive for immunofluorescent HEp-2 ANAs. The assay is used as an aid in the diagnosis of Systemic Lupus Erythematosus, Mixed Connective Tissue Disease, Sjögren's Syndrome, Progressive Systemic Sclerosis, and Polymyositis/Dermatomyositis, and should be used in conjunction with other laboratory tests and clinical findings.
    Device Description
    The assay requires a total of 90 minutes incubation time. The test uses antigen coated on microtiter wells. Serum is added to each well and incubated for 30 minutes at room temperature. If antibodies are present they will bind to the antigen in the well. Unbound serum is removed by washing the wells three times. An HRP-conjugated anti-human IgG is then added to each well and incubated for 30 minutes at room temperature. If antibody is present, it will bind to the antibody attached to the antigen on the well. The wells are again washed three times to remove any unbound conjugate. A TMB substrate is added to each well and incubated for 30 minutes at room temperature. If enzyme is present, it will react with the substrate to generate a colored product. After the incubation period, the reaction is stopped with a Stop Solution and the color intensity is measured spectrophotometrically.
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    K Number
    K131185
    Device Name
    ANA SCREEN ELISA (IGG)
    Manufacturer
    EUROIMMUN US
    Date Cleared
    2013-07-15

    (80 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN ANA Screen ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against nuclear antigens (mixture of dsDNA, histones, ribosomal P-proteins, rRNP/Sm, Sm, SS-A, SS-B, Scl-70, Jo-1 and centromeres) in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of mixed connective tissue diseases (MCTD), systemic lupus erythematosus, Sjögren's syndrome, progressive systemic sclerosis and polymyositis and dermatomyositis, in conjunction with other laboratory and clinical findings.
    Device Description
    The EUROIMMUN ANA Screen ELISA (IgG) consists of a microwell ELISA plate coated with a mixture of dsDNA, histones, ribosomal P proteins, nRNP/Sm, Sm, SS-A, SS-B, Scl-70. Jo-1 and centromeres antigens, calibrator, positive and negative control, peroxidaselabeled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
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    K Number
    K083188
    Device Name
    VARELISA RECOMBI ANA SCREEN, MODEL 12 596
    Manufacturer
    PHADIA US INC.
    Date Cleared
    2009-03-13

    (135 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa ReCombi ANA Screen EIA kit is designed for the qualitative determination of eight antinuclear antibodies in human serum or plasma (citrate/EDTA) to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polymyositis/ dermatomyositis. The Varelisa ReCombi ANA Screen detects antibodies against dsDNA, UIRNP (RNP70, A, C), Sm, SS-A/Ro (52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B and Jo-1 in a single microwell.
    Device Description
    The Varelisa ReCombi ANA Screen is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of antinuclear antibodies in serum and plasma (citrate/EDTA). Designed as a screening assay, it detects eight antinuclear antibodies in a single microwell. The determination of antinuclear antibodies (ANA) is of central importance for the clinical diagnosis of rheumatic diseases. The presence of ANA suggests the possibility of rheumatic autoimmune diseases, These diseases include Systemic Lupus Erythemtosus (SLE), Polymyositis/ Dematomyositis, Scleroderma, Sjögren's Syndrome and Mixed Conective Tissue Diseases.
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    K Number
    K050967
    Device Name
    VARELISA RECOMBI CTD SCREEN, MODEL 13096
    Manufacturer
    SWEDEN DIAGNOSTICS (GERMANY) GMBH
    Date Cleared
    2005-06-28

    (71 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa ReCombi CTD Screen EIA kit is designed for the qualitative determination of ten antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), drug-induced lupus, scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polymyositis/dermatomyositis. The Varelisa ReCombi CTD Screen detects antibodies against dsDNA, RNP (RNP70,A,C), Sm (B,B',D), SS-A/Ro(52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B, Histone, Ribosomal P Protein and Jo-1 in a single microwell.
    Device Description
    The new device is an enzyme-linked immunosorbent assay (ELISA) using microtiter plates as the solid phase. The plate wells are coated with antinuclear antigens, which allow anti-nuclear antibodies (sample) to react with the immobilized antigens. The conjugate is rabbit anti-human IgG horseradish peroxidase (HRP), which uses 3, 3'5, 5' tetramethylbenzidine dihydrochloride (TMB) as substrate. The kit contains calibrator and negative control. The kit also contains sample diluent, wash buffer concentrate and stop solution.
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    K Number
    K050625
    Device Name
    VARELISA RECOMBI ANA PROFILE, MODEL 18496
    Manufacturer
    SWEDEN DIAGNOSTICS (GERMANY) GMBH
    Date Cleared
    2005-04-26

    (46 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa ReCombi ANA Profile EIA kit is designed for the qualitative determination of eight antinuclear antibodies in human serum or plasma to aid in the diagnosis of SLE (systemic lupus erythematosus), scleroderma (progressive systemic sclerosis and CREST syndrome), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polymyositis/dermatomyositis. The Varelisa ReCombi ANA Profile individually detects antibodies against dsDNA, U1 RNP (RNP 70 kDa,A,C), SmD, SS-A/Ro(52 kDa, 60 kDa), SS-B/La, Scl-70, CENP-B and Jo-1.
    Device Description
    The new device is an enzyme-linked immunosorbent assay (ELISA) using microtiter plates as the solid phase. Plate wells each coated with 1 of 8 different ANA antigens are included to allow corresponding antibodies in the patient samples react with the immobilized antigens. The conjugate is rabbit anti-human IgG horseradish peroxidase (HRP), which uses 3, 3'5, 5' tetramethylbenzidine dihydrochloride (TMB) as substrate. The kit contains a calibrator and a negative control. The kit also contains sample diluent, wash buffer concentrate and stop solution.
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    K Number
    K041102
    Device Name
    IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2004-10-26

    (182 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An enzyme linked immunoassay (ELISA) for the detection of antinuclear and cytoplasmic antibodies in human serum to aid in the diagnosis of autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome (SS), Mixed Connective Tissue Disease (MCTD), and Scleroderma.
    Device Description
    An enzyme linked immunoassay (ELISA)
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