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510(k) Data Aggregation

    K Number
    K202541
    Device Name
    EliA RNA Pol III
    Manufacturer
    Phadia AB
    Date Cleared
    2021-09-13

    (376 days)

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

    NYO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EliA RNA Pol III is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNA polymerase III (RNA Pol III) in human serum as an aid in the diagnosis of systemic sclerosis (diffuse form) in conjunction with other laboratory and clinical findings. EliA RNA Pol III uses the EliA IgG method.
    Device Description
    EliA RNA Pol III is a semi-quantitative solid-phase fluoroenzymeimmunoassay, for the determination of autoantibodies against RNA polymerase III. The EliA RNA Pol III test System is fully integrated and automated system which comprises of assay-specific reagents, EliA method-specific reagents, and general reagents.
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    K Number
    K172078
    Device Name
    ImmuLisa Enhanced RNA POL III Antibody ELISA
    Manufacturer
    IMMCO Diagnostics, Inc.
    Date Cleared
    2018-03-30

    (263 days)

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

    NYO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-RNA POL III IgG antibodies in human serum as an aid in diagnosis of systemic scleroderma) in conjunction with other laboratory and clinical findings.
    Device Description
    An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-RNA POL III IgG antibodies in human serum as an aid in diagnosis (scleroderma) in conjunction with other laboratory and clinical findings. This test is performed as a solid phase immunoassay. Microwells are coated with recombinant RNA POLIII antigen. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the RNA POL III antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgG conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected 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
    K070066
    Device Name
    QUANTA LITE RNA POL III ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2007-04-11

    (93 days)

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

    NYO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QUANTA Lite™ RNA Pol III ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-RNA Polymerase III antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic sclerosis (scleroderma) with increased incidence of skin involvement and renal crisis.
    Device Description
    Not Found
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    K Number
    K060431
    Device Name
    ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805
    Manufacturer
    MBL INTERNATIONAL CORPORATION
    Date Cleared
    2006-06-19

    (118 days)

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

    NYO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The anti-RNA Polymerase III ELISA Kit is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of anti-RNA Polymerase III antibodies in human serum. The test result is used as an aid in the diagnosis of Systemic Sclerosis (SSc) in conjunction with the clinical and other laboratory findings. The anti-RNA Polymerase III ELISA Kit is intended for in-vitro diagnostic use.
    Device Description
    This device is an aid to the diagnosis of SSc. Systemic sclerosis (SSc) is an autoimmune disease characterized by microvascular damage and fibrosis of the skin and internal organs. RNA polymerase(RNAP) I, II and III are major targets of autoantibody responses in SSc patients. Each RNAP catalyzes transcription of unique sets of genes: RNAP I transcribes ribosomal RNA genes, RNAP II transcribes all protein coding genes and several small nuclear RNA genes, and RNAP III transcribes genes that produce small stable RNAs including 5S and transfer RNAs. Anti-RNAP I and anti-RNAP III antibodies are almost always present together (anti-RNAP I/II), and some sera contain anti-RNAP II antibody as well. Anti-RNAP I/II antibodies are the most common SSc related antibodies in white North American patients with SSc and is associated with diffuse cutaneous involvement, a high frequency of "renal crisis", and high mortality. In addition, it has been shown that some SSc sera contain autoantibodies recognizing RNAP II but not RNAP I or III. Antibodies to RNAP II are also present in sera from some patients with systemic lupus erythematosus (SLE) or overlap syndrome. PRINCIPLE: The anti-RNA Polymerase III ELISA Kit measures anti-RNAP III antibodies present in the serum by ELISA. Diluted Calibrators and patient serum are added to microwell coated with RNAP III antigens, allowing anti-RNAP III antibodies to react with the immobilized antigen (Sample incubation). After washing to remove any unbound serum proteins, horseradish peroxidase conjugated anti human IgG is added and incubated (Conjugate incubation). Following another washing step, the peroxidase substrate is added and incubated for an additional period of time (Substrate incubation). Acid solution is then added to each well to terminate the enzyme reaction and to stabilize the color development. The assay can be quantified by measuring the reaction photometrically and plotting the results.
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