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510(k) Data Aggregation

    K Number
    K191442
    Device Name
    Campylobacter Chek
    Manufacturer
    Techlab, Inc.
    Date Cleared
    2019-06-20

    (21 days)

    Product Code
    LQP
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    Techlab, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    for the indications for use stated in the enclosure
    Device Description
    Not Found
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    K Number
    K181379
    Device Name
    H. PYLORI QUIK CHEK
    Manufacturer
    TECHLAB, Inc.
    Date Cleared
    2018-08-21

    (89 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHLAB, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.
    Device Description
    The H. PYLORI QUIK CHEK™ test utilizes antibodies specific for H. pylori antigen. The Membrane Device contains a Reaction Window with two vertical lines of immobilized antibodies. The test line ("T") contains antibodies specific for H, pylori antigen. The ("C") contains antibodies to horseradish peroxidase (HRP). The Conjugate consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. To perform the test, the sample is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any H. pylori antigen in the sample binds to the antibody-peroxidase conjugate. The antigen-antibody-peroxidase complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-H. pylori antigen antibodies in the test line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation period, the Reaction Window is examined visually for the appearance of vertical blue lines on the "C" and "T" sides of the Reaction Window. A blue line on the "T" side of the Reaction Window indicates a positive result. A positive "C" reaction, indicated by a vertical blue line on the "C" side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay.
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    K Number
    K181400
    Device Name
    H. PYLORI CHEK™
    Manufacturer
    TECHLAB, Inc.
    Date Cleared
    2018-08-21

    (84 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHLAB, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TECHLAB H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consician in conjunction with the patient history and symptoms.
    Device Description
    The H. PYLORI CHEK™ test uses antibodies specific to H. pylori antigen. The Microassay Plate in the kit contains immobilized capture antibodies aqainst H. pylori antigen. The Conjugate consists of antibodies specific to H, pylori antigen conjucated to horseradish peroxidase. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well containing the Conjugate. If the antigen is present in the specimen, it will bind to the Coniugate and to the immobilized capture antibody during the incubation phase. Any unbound material is 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 antigen.
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    K Number
    K173217
    Device Name
    CAMPYLOBACTER QUIK CHEK
    Manufacturer
    Techlab, Inc.
    Date Cleared
    2018-01-22

    (111 days)

    Product Code
    LQP
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    Techlab, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.
    Device Description
    The CAMPYLOBACTER QUIK CHEK™ test uses antibodies that recognize a Campylobacter-specific antigen in human fecal samples. The device contains a Reaction Window with two vertical lines of immobilized antibodies. The test line ("T") contains antibodies against a Campylobacter-specific antigen. The control line ("C"), contains anti-IgG antibodies. The Conjugate consists of antibodies to a Campylobacter-specific antigen coupled to horseradish peroxidase. To perform the test, a fecal specimen is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, the Campylobacter-specific antigens in the sample bind to the antibody-peroxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-Campylobacter antibodies in the line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation, the "T" reaction is examined visually for the appearance of a vertical blue line. A blue line indicates a positive "C" reaction, indicated by a vertical blue line, monitors/confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay and that the results are valid.
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    K Number
    K173219
    Device Name
    CAMPYLOBACTER CHEK
    Manufacturer
    Techlab, Inc.
    Date Cleared
    2018-01-22

    (111 days)

    Product Code
    LQP
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    Techlab, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.
    Device Description
    The CAMPYLOBACTER CHEK™ test uses antibodies that recognize a Campylobacter-specific antigen. The Microassay Plate in the kit contains immobilized capture monoclonal antibodies against a Campylobacter-specific antigen. The Conjugate consists of polyclonal antibodies to a Campylobacter-specific antigen conjugated to horseradish peroxidase. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well containing the Conjugate. If the antigen is present in the specimen, it will bind to the Conjugate and to the immobilized capture antibody during the incubation phase. Any unbound material is 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 antigen.
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    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?
    Applicant Name (Manufacturer) :

    Techlab, Inc.

    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
    K170728
    Device Name
    E. HISTOLYTICA QUIK CHEK
    Manufacturer
    TECHLAB, Inc.
    Date Cleared
    2017-06-07

    (90 days)

    Product Code
    KHW
    Regulation Number
    866.3220
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHLAB, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TECHLAB® E. HISTOLYTICA QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of adhesin from Entamoeba histolytica in a single use cassette. It is intended for use with human fecal specimens from patients with diarrhea or dysentery as an aid in the diagnosis of E. histolytica gastrointestinal infection. Test results should be considered in conjunction with patient history. FOR IN VITRO DIAGNOSTIC USE
    Device Description
    The E. HISTOLYTICA QUIK CHEK™ test uses antibodies to adhesin. The device contains a Reaction Window with two vertical lines of immobilized antibodies. The test line ("T") contains monoclonal antibodies specific for E. histolytica adhesin. The control line ("C") contains antibodies to horseradish peroxidase (HRP). The Conjugate consists of polyclonal antibodies to E. histolytica adhesin coupled to horseradish peroxidase. To perform the test, the sample is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, E. histolytica adhesin in the samples bind to the antibodyperoxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized antibodies in the Reaction Window is subsequently washed with Wash Buffer, and the test is developed with the addition of Substrate. After a 10 minute incubation period, the "T" reaction is examined visually for the appearance of a vertical blue line on the "T" side of the Reaction Window. A blue line indicates a positive test. A positive "C" reaction, indicated by a vertical blue line on the "C" side of the Reaction Window, monitors/confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay.
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    K Number
    K082499
    Device Name
    C. DIFF QUIK CHEK COMPLETE
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    2009-03-26

    (209 days)

    Product Code
    LLH
    Regulation Number
    866.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHLAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C. DIFF QUIK CHEK COMPLETE™ test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    The C. DIFF QUIK CHEK COMPLETE™ test uses antibodies specific for qlutamate dehydrogenase (GDH) and Toxins A and B of C. difficile. The device contains a Reaction Window with two solid lines and a dotted line of immobilized antibodies. The Antigen line ("Ag") contains antibodies against C. difficile GDH. The Toxin line ("Tox") contains antibodies against C. difficile toxins A and B. The dotted line, representing a control line ("C"), contains anti-HRP antibodies. The Conjugate consists of antibodies to GDH, toxin A, and toxin B coupled to horseradish peroxidase. To perform the test, the fecal specimen is diluted with Diluent, and Conjugate is added to the diluted sample. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any GDH, toxin A or toxin B in the sample binds to the corresponding antibody-peroxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-GDH, anti-toxin A or Anti-toxin B antibody in the line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation, the "Ag" and "Tox" reaction is examined visually for the appearance of a blue line. A blue line indicates a positive test. A positive "C" reaction, indicated by a blue dotted line, confirms that sample and all reagents were added in proper sequence and volume, that reagents were active at the time of performing the assay, and that proper sample migration occurred.
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    K Number
    K053572
    Device Name
    C. DIFF QUIK CHEK
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    2006-04-26

    (125 days)

    Product Code
    MCB
    Regulation Number
    866.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHLAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C. DIFF QUIK CHEK™ test is a rapid membrane enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, the test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    The C. DIFF QUIK CHEK™ test uses antibodies specific for glutamate dehydrogenase (GDH) of C. difficile. The device contains a Reaction Window with two lines of immobilized antibodies. The test line ("T") contains antibodies against C. difficile GDH. The other, representing a control line ("C"), contains anti-IgG antibodies. The Conjugate consists of antibody to GDH coupled to horseradish peroxidase. To perform the test, the fecal specimen is diluted with Diluent, and Conjugate is added to the diluted sample. The diluted sample conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any GDH in the sample binds to antibodyperoxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-GDH antibody in the line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After up to a 10-minute incubation, the "T" reaction is examined visually for the appearance of a blue line indicates a positive test. A positive "C" reaction, indicated by a blue line, confirms that sample and all reagents were added in proper sequence and volume, that reagents were active at the time of performing the assay, and that proper sample migration occurred.
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    K Number
    K051927
    Device Name
    TECHLAB ASCA-CHEK
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    2006-04-06

    (262 days)

    Product Code
    NBT
    Regulation Number
    866.5785
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHLAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TECHLAB® ASCA-CHEK test is an ELISA for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces. The test result is used as an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    The TECHLAB® ASCA-CHEK test is an enzyme-linked immunoassay (ELISA) for the measurement of human anti-S. cerevisiae antibodies in feces as an aid in the diagnosis of Crohn's disease. The assay utilizes antigens of S. cerevisiae for capture and a polyvalent anti-human immunoglobulin conjugate. When human ASCA is present in the fecal specimen, the specific immunoglobulins bind to the S. cerevisiae antigens that are immobilized in the test well. Following this binding step, the polyvalent anti-human horseradish peroxidase (HRP) conjugate binds to the ASCA and reacts with the substrate to produce a positive result. The measurement of fecal ASCA is an aid in the diagnosis of Crohn's disease within the setting of differentiating Crohn's disease from ulcerative colitis. This noninvasive diagnostic method is simple to perform and requires only a fecal specimen for the analysis.
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