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510(k) Data Aggregation

    K Number
    K171078
    Device Name
    TRI-COMBO PARASITE SCREEN
    Manufacturer
    Techlab, Inc.
    Date Cleared
    2017-07-10

    (90 days)

    Product Code
    MHJ, KHW, MHI
    Regulation Number
    866.3220
    Why did this record match?
    Product Code :

    MHJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TECHLAB® TRI-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis.
    Device Description
    The TRI-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test uses monoclonal and polyclonal antibodies to cell-surface antigens of Giardia, Cryptosporidium and E. histolytica. The microassay plate in the kit contains immobilized monoclonal antibodies against the antigens, and the Conjugate consists of polyclonal antibodies against the antigens. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well. The immobilized monoclonal antibodies bind the Giardia, Cryptosporidium and/or E. histolytica antigens if they are present. Upon addition, Conjugate then binds to the antigen/ antibody complex. Any unbound materials are removed during the washing steps. Following the addition of Substrate, a color is detected due to the enzyme-antibody-antigen complexes that formed in the presence of antigens and conjugate.
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    K Number
    K121565
    Device Name
    UNI-GOLD CRYPTOSPORIDIUM
    Manufacturer
    TRINITY BIOTECH
    Date Cleared
    2013-02-08

    (255 days)

    Product Code
    MHJ
    Regulation Number
    866.3220
    Why did this record match?
    Product Code :

    MHJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Trinity Biotech Uni-Gold™ Cryptosporidium is a single use rapid immunoassay for the qualitative detection of Cryptosporidium parvum (C. parvum) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Cryptosporidium gastrointestinal infections. As with other Cryptosporidium tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.
    Device Description
    The Trinity Biotech Uni-Gold™ Cryptosporidium Test was designed as a single use, rapid, lateral flow immunoassay to detect the presence of Cryptosporidium parvum antigen in unpreserved (fresh & frozen), preserved, and media containing human stool specimens. The Trinity Biotech Uni-Gold™ Cryptosporidium test strip (5mm x 60mm) combines a nitrocellulose membrane with designated fiber pads (conjugate, sample and absorbant). The test strip is then placed into a plastic housing and is sealed constituting the Test Device.
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    K Number
    K051929
    Device Name
    GIARDIA/CRYPTOSPORIDIUM CHEK
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    2005-11-17

    (127 days)

    Product Code
    MHJ, MHI
    Regulation Number
    866.3220
    Why did this record match?
    Product Code :

    MHJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GIARDIA/CRYPTOSPORIDIUM CHEK™ test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections.
    Device Description
    The GIARDIA/CRYPTOSPORIDIUM CHEK™ test uses monoclonal and polyclonal antibodies to cell-surface antigens of Giardia and an oocyst antigen of Cryptosporidium. The Microassay Plate in the kit contains immobilized monoclonal antibodies against the antigens and the Conjugate consists of polyclonal antibodies against the antigens. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well. The immobilized monoclonal antibodies bind the Giardia and Cryptosporidium antigens if the antigens are present. Upon addition, Conjugate then binds to the antigen/antibody complex. Any unbound materials are removed during the washing steps. Following the addition of substrate, a color is detected due to the enzyme-antibody-antigen complexes that formed in the presence of Giardia or Cryptosporidium antigens and Conjugate.
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    K Number
    K052932
    Device Name
    CRYPTOSPORIDIUM II
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    2005-11-04

    (16 days)

    Product Code
    MHJ
    Regulation Number
    866.3220
    Why did this record match?
    Product Code :

    MHJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    Not Found
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    K Number
    K031965
    Device Name
    XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
    Manufacturer
    REMEL INC
    Date Cleared
    2003-11-14

    (141 days)

    Product Code
    MHJ
    Regulation Number
    866.3220
    Why did this record match?
    Product Code :

    MHJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REMEL's Xpect™ Cryptosporidium kit is an in vitro qualitative immunoassay for the detection of Cryptosporidium antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Cryptosporidium infections.
    Device Description
    The Xpect™ Cryptosporidium Lateral Flow Assay is a chromatographic immunoassay that detects the presence of Cryptosporidium antigen. The test utilizes sample wicking to capture Cryptosporidium antigen on a test line containing antigen-specific antibody. A specimen is added to a dilution tube containing a buffered solution. A conjugate containing colored micro-particles linked to murine monoclonal antibody specific for Cryptosporidium is added. The mixture is dispensed into the sample well of the device and wicks along a membrane containing capture antibody stripes. The Cryptosporidium immune complex, if present, reacts with anti-Cryptosporidium antibody at the test line. Conjugate not bound at the test line is later captured at the control line containing anti-mouse antibody. A red line of any intensity will appear at the Cryptosporidium test position if Cryptosporidium antigen is present. A line in the Control position indicates that the test is working properly.
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    K Number
    K031059
    Device Name
    IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
    Manufacturer
    IVD RESEARCH, INC.
    Date Cleared
    2003-07-10

    (104 days)

    Product Code
    MHJ
    Regulation Number
    866.3220
    Why did this record match?
    Product Code :

    MHJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This microwell enzyme linked immunoabsorbant assay (ELISA) detection kit is an in vitro diagnostic (IVD) immunoassay for the detection of Cryptosporidium antigen in human feces using peroxidase as the enzyme. The assay may be read visually or with an ELISA reader. This IVD assay is intended to be used with stools that are fresh, frozen or preserved in 10% formalin, SAF or Medical Chemical Corporation's (MCC) Universal fixative. Concentrated samples cannot be used with this IVD.
    Device Description
    This microwell enzyme-linked immunoabsorbant assay (ELISA) detection kit (Cryptosporidium ELISA Kit) is an in vitro diagnostic (IVD) immunoassay for the detection of antigen to Cryptosporidium species in human feces using peroxidase as the indicator enzyme. The assay may be read visually or with an ELISA reader. Concentrated fecal samples cannot be used with this immunoassay. Rather, this IVD Cryptosporidium ELISA Kit is intended to be used with human stools that are fresh, frozen or preserved in 10% formalin, SAF or Medical Chemical Corporation's (MCC's) Universal fixative in a clinical laboratory use setting. This ELISA is an in vitro immunoassay for the qualitative determination of Cryptosporidium species antigen in feces. The ELISA uses a rabbit anti-Cryptosporidium antibody to capture the antigen from the stool supernatant. A second goat anti-Cryptosporidium antibody is then added which sandwiches the captured antigen. This reaction is visualized by the addition of an anti-second antibody conjugated to peroxidase and the chromogen tetramethylbenzidine (TMB). The resulting blue color development indicates the presence of Cryptosporidium species antigens being bound by the anti-Cryptosporidium antibodies.
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    K Number
    K982764
    Device Name
    PREMIER CRYPTOSPORIDIUM
    Manufacturer
    MERIDIAN DIAGNOSTICS, INC.
    Date Cleared
    1998-12-03

    (119 days)

    Product Code
    MHJ
    Regulation Number
    866.3220
    Why did this record match?
    Product Code :

    MHJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Premier Cryptosporidium enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Cryptosporidium antigens in stool. Test results are intended to aid in the diagnosis of Cryptosporidium infection.
    Device Description
    The assay is a conventional microwell sandwich enzyme immunoassay, utilizing polyclonal capture and monoclonal detection antibodies.
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    K Number
    K982709
    Device Name
    MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
    Manufacturer
    ALEXON - TREND, INC.
    Date Cleared
    1998-09-03

    (30 days)

    Product Code
    MHJ
    Regulation Number
    866.3220
    Why did this record match?
    Product Code :

    MHJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProSpecT® Cryptosporidium Microplate Assay uses monoclonal antibodies for the qualitative detection of Cryptosporidium Specific Antigen (CSA) in aqueous extracts of fecal specimens.
    Device Description
    ProSpecT® Cryptosporidium Microplate Assay
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    K Number
    K980354
    Device Name
    CRYPTOSPORIDIUM TEST
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    1998-05-18

    (109 days)

    Product Code
    MHJ
    Regulation Number
    866.3220
    Why did this record match?
    Product Code :

    MHJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cryptosporidium TEST is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of Cryptosporidium gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    The kit, which includes ready-to-use reagents, contains microtiter wells coated with monoclonal antibody, positive control reagent, detecting antibody (polyclonal antibody), conjugate (anti-rabbit IgG-peroxidase), substrates, wash solution, and stop solution. The microtiter wells coated with monoclonal antibody "capture" the antigen and the polyclonal antibody serves as the "detecting" antibody. The polyclonal antibody used as the detecting antibody is prepared from hyperimmune antiserum developed in rabbits. The monoclonal antibody used to coat microtiter wells is prepared from mouse ascites fluid.
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    K Number
    K955852
    Device Name
    CRYPTO-CEL IF TEST
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    1996-08-05

    (223 days)

    Product Code
    MHJ
    Regulation Number
    866.3220
    Why did this record match?
    Product Code :

    MHJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TechLab Crypto-Cel IF Test can be used to detect Cryptosporidium oocysts in fecal specimens from persons suspected of having intestinal disease due to this pathogen.
    Device Description
    The kit, which includes ready-to-use reagents, contains an antibody reagent consisting of FITC-labeled anti-Cryptosporidium monoclonal antibody. This antibody functions as the detecting antibodies. The monoclonal antibody is prepared from mouse ascites fluid.
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