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510(k) Data Aggregation

    K Number
    K981363
    Device Name
    ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST
    Manufacturer
    TCPI, INC.
    Date Cleared
    1998-12-22

    (251 days)

    Product Code
    LCM
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TCPI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TCPI's One Step™ Urine Drug of Abuse: Phencyclidine (PCP) Test is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. TCPI's One Step™ Urine Drug of Abuse: Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.
    Device Description
    TCPI's One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test Strip is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine. The One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test Strip is a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for a limited number of antibody binding sites. As a test sample flows up through the absorbent device, labeled antibody-dye conjugate binds to free drug in the specimen, forming an antibody-antigen complex. This complex with immobilized antigen conjugate in the Test Zone of the strip, and will not produce a magenta color band when the drug concentration in the specimen is above the detection level of 25 ng/ml. Unbound dye conjugate birds to the reagent in the Control Zone of the strip, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A negative specimen produces two distinct color bands, one in the Test Zone and one in the Control Zone A positive specimen produces only one color band in the Control Zone.
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    K Number
    K972960
    Device Name
    HEALTH CHECK URI-TEST PROTEIN IN URINE
    Manufacturer
    TCPI, INC.
    Date Cleared
    1998-10-07

    (422 days)

    Product Code
    JIR
    Regulation Number
    862.1645
    Why did this record match?
    Applicant Name (Manufacturer) :

    TCPI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UriTest- Protein in Urine is a non-quantitative screening test to identify protein in urine. Protein in urine can be associated with renal, kidney or bladder disease.
    Device Description
    Not Found
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    K Number
    K981197
    Device Name
    ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST
    Manufacturer
    TCPI, INC.
    Date Cleared
    1998-06-16

    (75 days)

    Product Code
    DKZ
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    TCPI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TCPI One Step™ Urine Drug of Abuse Amphetamine Test is a rapid, qualitative, competitive binding immunoassay for the determination of Amphetamine in urine. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The TCPI One Step™ Urine Drug of Abuse Amphetamine assay is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.
    Device Description
    TCPI's One Step™ Urine Drug of Abuse Amphetamine Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 500 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
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    K Number
    K980776
    Device Name
    ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST
    Manufacturer
    TCPI, INC.
    Date Cleared
    1998-04-29

    (58 days)

    Product Code
    JXM
    Regulation Number
    862.3170
    Why did this record match?
    Applicant Name (Manufacturer) :

    TCPI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Technical Chemicals and Products, Inc.'s One Step™ Urine Drug of Abuse: Benzodiazepine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Benzodiazepine in urine at the cutoff level of 200 ng/ml. The test provides only preliminary data that should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Technical Chemicals and Products, Inc.'s One Step™ Urine Drug of Abuse: Benzodiazepine Test is not intended to monitor drug levels, but only to screen urine for the presence of Benzodiazepine and its metabolites.
    Device Description
    Technical Chemicals and Products. Inc.'s One Step™ Urine Drug of Abuse: Benzodiazepine Test, consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 200 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
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    K Number
    K951853
    Device Name
    ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)
    Manufacturer
    TCPI, INC.
    Date Cleared
    1996-08-20

    (487 days)

    Product Code
    LDJ
    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    TCPI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for medical/forensic screening of urine.
    Device Description
    TCPI's One Step™ Urine Drug of Abuse Cannabinoids test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 50 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
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    K Number
    K954968
    Device Name
    HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
    Manufacturer
    TCPI, INC.
    Date Cleared
    1996-07-26

    (273 days)

    Product Code
    JIL
    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    TCPI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954685
    Device Name
    URITEST - NITRITE IN URINE TEST
    Manufacturer
    TCPI, INC.
    Date Cleared
    1996-07-22

    (285 days)

    Product Code
    JMT
    Regulation Number
    862.1510
    Why did this record match?
    Applicant Name (Manufacturer) :

    TCPI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UriTest- Nitrite in Urine is a nonquantitative test to identify nitrite in urine. Nitrite identification is used for the detection of Urinary Tract Infection.
    Device Description
    UriTest - Nitrite in Urine is a reagent strip test used to measure the presence of Nitrite in urine. Nitrite is produced by most organisms commonly associated with urinary tract infection. Nitrite is used to detect urinary tract infection.
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    K Number
    K955353
    Device Name
    ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT
    Manufacturer
    TCPI, INC.
    Date Cleared
    1996-03-19

    (119 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    TCPI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Technical Chemicals and Products Inc. ("TCPI") One Step™ Pregnancy hCG strip assay is a qualitative, sandwich dye conjugate immunoassay for the determination of Human Chorionic Gonadotropin in urine or serum.
    Device Description
    The method employs a unique combination of monoclonal and polyclonal antibodies to selectively identify hCG in test samples with a high degree of sensitivity using a unique patented membrane technology. In less than 5 minutes, elevated levels of hCG as low as 25 mIU/ml can be detected. If the test is to be used on serum the sample must be diluted according to the directions for the One Step™ Pregnancy hCG serum diluent (cat XXXX). As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a pink-rose color band when hCG concentration is greater than 25 mIU/ml. In the absence of hCG, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the positive reaction zone and negative zone. Unbound conjugate binds to the reagents in the negative control zone, producing a pink-rose (magenta) color band, demonstrating that the reagents and device are functioning correctly.
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