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510(k) Data Aggregation

    K Number
    K231020
    Device Name
    Alinity c Tricyclic Antidepressants Reagent Kit
    Manufacturer
    Microgenics Corporation
    Date Cleared
    2023-11-17

    (221 days)

    Product Code
    LFH
    Regulation Number
    862.3910
    Why did this record match?
    Product Code :

    LFH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alinity c Tricyclic Antidepressants Reagent Kit is a homogeneous enzyme immunoassay intended for use in the qualitative and/or semiquantitative determination of the presence of tricyclic antidepressants (TCAs) in human serum or plasma at a cutoff concentration of 300 ng/mL on the Alinity c system in patients suspected of drug overdose. The semiquantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS), or for permitting laboratories to establish control procedures. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. For In Vitro Diagnostic Use Only.
    Device Description
    The Alinity c Tricyclic Antidepressants Reagent Kit is an automated clinical chemistry assay and a homoqeneous enzyme immunoassay using ready-to-use liquid reagents. The assay uses polyclonal antibodies that detect most tricyclic antidepressants in serum or plasma. The assay is based on the competition between an enzyme-labeled drug and the drug from the serum or plasma for a fixed number of specific antibody binding sites. In the absence of drug from the sample, the specific antibody binds to the drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) and the enzyme activity is inhibited. This phenomenon creates a direct relationship between the drug concentration in the serum or plasma and the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340/416 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH. The Alinity c Tricyclic Antidepressants Reagent Kit is supplied as a two liquid reagent kit (R1 and R2). They are included within the same kit, see details below: - Antibody/Substrate Reagent (R1): Contains polyclonal anti-tricyclics antibodies ● (sheep), glucose-6- phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as a preservative. - Enzyme Conjugate Reagent (R2): Contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with nortriptyline in Tris buffer with sodium azide as a preservative.
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    K Number
    K213875
    Device Name
    DRI TM Tricyclics Serum Tox Assay
    Manufacturer
    Microgenics Corporation
    Date Cleared
    2022-12-21

    (373 days)

    Product Code
    LFH
    Regulation Number
    862.3910
    Why did this record match?
    Product Code :

    LFH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRI™ Tricyclics Serum Tox Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semiquantitative determination of the presence of tricyclic antidepressants (TCAs) in human serum, plasma, or urine of patients at a cutoff concentration of 300 ng/mL in patients suspected of drug overdose. The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures. The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. For In Vitro Diagnostic Use Only.
    Device Description
    The DRI™ Tricyclics Serum Tox Assay is a homogeneous enzyme immunoassay using ready to-use liquid reagents. Specific tricyclic antibodies were used to detect most tricyclic antidepressants in serum, plasma, or urine. The test is based on the competition of an enzyme, glucose-6-phosphate dehydrogenase (G6PDH), labeled-drug and the drug from the sample for a fixed amount of specific antibody binding sites. In the absence of the drug from the sample, the specific antibody binds the enzyme-labeled drug and the enzyme activity is inhibited. This phenomenon creates a direct relationship between drug concentration in the sample and the enzyme activity. The enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH. The DRI™ Tricyclics Serum Tox assay is supplied as a two liquid reagent kit (Reagent A and Reagent E). Thev are bottled separately within the same kit, see details below: - Antibody/Substrate Reagent (Reagent A): Contains polyclonal anti-tricyclics . antibodies (sheep), glucose-6- phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as a preservative. - Enzyme Conjugate Reagent (Reagent E): Contains glucose-6-phosphate ● dehydrogenase (G6PDH) labeled with nortriptyline in Tris buffer with sodium azide as a preservative.
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    K Number
    K983268
    Device Name
    MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
    Manufacturer
    DIAGNOSTIC REAGENTS, INC.
    Date Cleared
    1998-11-18

    (62 days)

    Product Code
    LFH
    Regulation Number
    862.3910
    Why did this record match?
    Product Code :

    LFH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This homogeneous tricyclics serum tox enzyme immunoassay is intended to be used for qualitative and semiquantitative determination of tricyclic antidepressants in serum, plasma or urine of patients suspected of drug overdose. A 300 ng/mL nortriptyline cutoff calibrator is used in this assay to differentiate a positive from a negative sample. Detection of the drug presence and its approximate concentration in serum, plasma or urine from patients suspected of drug overdose can assist the physician in diagnosis and determination of steps towards treatment.
    Device Description
    homogeneous tricyclics serum tox enzyme immunoassay
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    K Number
    K981801
    Device Name
    ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
    Manufacturer
    PRINCETON BIOMEDITECH CORP.
    Date Cleared
    1998-08-25

    (96 days)

    Product Code
    LFH, LFG, LFI
    Regulation Number
    862.3910
    Why did this record match?
    Product Code :

    LFH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoassay for the qualitative detection of Tricyclic Immunoassay for the quarteline at cutoff 1000 ng/mL) in human urine to assist in screening of drug of abuse samples.
    Device Description
    Not Found
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    K Number
    K961393
    Device Name
    TRICYCLICS SERUM TOX ASSAY
    Manufacturer
    DIAGNOSTIC REAGENTS, INC.
    Date Cleared
    1996-06-12

    (62 days)

    Product Code
    LFH
    Regulation Number
    862.3910
    Why did this record match?
    Product Code :

    LFH

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