Search Filters

Search Results

Found 9 results

510(k) Data Aggregation

    K Number
    K032330
    Device Name
    CT OIA
    Manufacturer
    THERMO BIOSTAR, INC.
    Date Cleared
    2004-03-02

    (217 days)

    Product Code
    LJC
    Regulation Number
    866.3120
    Why did this record match?
    Product Code :

    LJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermo Electron CT OIA assay is an Optical ImmunoAssay (OIA) test for the rapid, qualitative detection of chlamydial antigen from female endocervical swab specimens. This test is intended for in vitro diagnostic use as an aid in identifying the presence of Chlamydia trachomatis antigen. The assay is intended for in vitro diagnostic use with symptomatic females in populations at risk for sexually transmitted diseases. CT OIA test results are presumptive evidence for either the presence or absence of C. trachomatis. Definitive laboratory evidence for the presence/ absence of C. trachomatis would need additional testing. CT OIA test results should not preclude empiric treatment of women with overt symptoms of PID. Performance for use in asymptomatic male and female populations has not been established.
    Device Description
    The CT OIA test involves the qualitative extraction of antigen specific to the Chlamydia genus. The Optical ImmunoAssay technology enables the direct visual detection of a physical change in the optical thickness of molecular thin films. This change is a result of antigen-antibody binding on an optical surface (silicon wafer). When an extracted specimen is placed directly on the optical surface, the immobilized specific antibodies capture the antigen. After washing, the substrate is added, increasing the thickness (mass enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color change. Slight changes in optical thickness produce a distinct, visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the surface retains the original gold color indicating a negative result.
    Ask a Question
    K Number
    K033865
    Device Name
    IDEIA PCE CHLAMYDIA
    Manufacturer
    DAKOCYTOMATION LTD
    Date Cleared
    2004-01-21

    (40 days)

    Product Code
    LJC
    Regulation Number
    866.3120
    Why did this record match?
    Product Code :

    LJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DakoCytomation Ltd IDEIA™ PCE Chlamydia is an immunoassay utilising dual amplification technology for the qualitative detection of Chlamydia lipopolysaccharide antigen in human urethral and endocervical swabs and male urines.
    Device Description
    Not Found
    Ask a Question
    K Number
    K033079
    Device Name
    CHLAMYDIA IGG ELISA TEST SYSTEM
    Manufacturer
    TRINITY BIOTECH USA
    Date Cleared
    2003-11-26

    (58 days)

    Product Code
    LJC
    Regulation Number
    866.3120
    Why did this record match?
    Product Code :

    LJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trinity Biotech Captia™ Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience.
    Device Description
    The Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies inhuman serum to Chlamydia for the determination of immunological experience. The Chlamydia IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Chlamydia. Purified Chlamydia antigen (strain LGV II) is attached to a solid phase microtiter well. Diluted test sera are added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is preset it will bind to the antibody attached to the antigen on the well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
    Ask a Question
    K Number
    K982210
    Device Name
    MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    1998-07-09

    (16 days)

    Product Code
    LJC
    Regulation Number
    866.3120
    Why did this record match?
    Product Code :

    LJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Syva MicroTrak II Chlamydia EIA is a n enzyme immunoassay intended for use in the qualitative detection of Chlamydia in female endocervical, male urethral, male urine and ocular specimens. The assay may be used to detect the presence of chlamydia where infection is suspected or likely to exist
    Device Description
    The Syva MicroTrak II Chlamydia EIA has been modified in that the preservative system in the Enzyme/Antibody reagent has been changed to meet USP Challenge test requirements and to be effective against pseudomonads and staphylococci. The modified preservative system meets those design requirements without affecting the performance characteristics, claims, and labeling of the assay as compared to the product with the unmodified preservative system.
    Ask a Question
    K Number
    K962558
    Device Name
    CHLAMYDIA IGG ELISA TEST SYSTEM
    Manufacturer
    ARMKEL, LLC.
    Date Cleared
    1997-02-24

    (238 days)

    Product Code
    LJC
    Regulation Number
    866.3120
    Why did this record match?
    Product Code :

    LJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience.
    Device Description
    The Chlamydia IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Chlamydia. Purified Chlamydia antigen (strain LGV II) is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
    Ask a Question
    K Number
    K960850
    Device Name
    ACCESS CHLAMYDIA ASSAY
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Date Cleared
    1997-02-04

    (340 days)

    Product Code
    LJC
    Regulation Number
    866.3120
    Why did this record match?
    Product Code :

    LJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    qualitative, paramagneticparticle, chemiluminescent enzyme immunoassays for the direction of chlamydia antigen in adult male urethral, female endocervical, and male urine specimens, using the ACCESS® Immunoassay System.
    Device Description
    The Sanofi Diagnostics Pasteur Inc. ACCESS® Chlamvdia antigen are qualitative, paramagneticparticle, chemiluminescent enzyme immunoassays for the direction of chlamydia antigen in adult male urethral, female endocervical, and male urine specimens, using the ACCESS® Immunoassay System.
    Ask a Question
    K Number
    K955627
    Device Name
    VIDAS CHLAMYDIA BLOCKING ASSAY
    Manufacturer
    BIOMERIEUX VITEK, INC.
    Date Cleared
    1996-10-07

    (301 days)

    Product Code
    LJC
    Regulation Number
    866.3120
    Why did this record match?
    Product Code :

    LJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    used as a supplemental test to verify positive and equivocal results from female endocervical and male urtheral specimens in the VIDAS Chlamydia (CHL) assay and is substantially equivalent to cell culture for the qualitative detection of Chlamydia antigen.
    Device Description
    The VIDAS Chlamydia Blocking assay is a fully automated enzyme-linked fluorescent immunoassay (ELFA) and requires only the addition of the blocking and reference reagents to the VIDAS Chlamydia strips.
    Ask a Question
    K Number
    K936054
    Device Name
    IMX SELECT CHLAMYDIA
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1996-05-30

    (891 days)

    Product Code
    LJC
    Regulation Number
    866.3120
    Why did this record match?
    Product Code :

    LJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMx SELECT Chlamydia is a Micropaticle Enzyme Immunoassay (MEIA) for the qualitative detection of chlamydial LPS antigen and is indicated for use in testing female endocervical swab specimens, and male urethral swab specimens from symptomatic individuals to identify Chlamvia trachomatis. The IMx SELECT Chamydia Blocking Reagent may be used to verify the chlamydial specificity of the antigen detected.
    Device Description
    Micropaticle Enzyme Immunoassay (MEIA) for the qualitative detection of chlamydial LPS antigen.
    Ask a Question
    K Number
    K940564
    Device Name
    IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION
    Manufacturer
    DAKO DIAGNOSTICS LTD.
    Date Cleared
    1996-01-11

    (707 days)

    Product Code
    LJC
    Regulation Number
    866.3120
    Why did this record match?
    Product Code :

    LJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1