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510(k) Data Aggregation

    K Number
    K993490
    Device Name
    QUICKSTRIP ONE STEP OPIATES TEST
    Manufacturer
    SYNTRON BIORESEARCH, INC.
    Date Cleared
    1999-10-29

    (14 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTRON BIORESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Syntron's QuikStrip One Step Opiates assay is a rapid, qualitative. competitive binding immunoassay for the determination of Opiates in urine at the cutoff level of 2000 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. Syntron's QuikStrip One Step Opiates Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiates and its metabolites.
    Device Description
    Syntron's QuikStrip One Step Opiates 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 2000 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
    K993491
    Device Name
    QUICKPAC II ONE STEP OPIATES TEST
    Manufacturer
    SYNTRON BIORESEARCH, INC.
    Date Cleared
    1999-10-29

    (14 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTRON BIORESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Syntron's QuikPac II One Step Opiates assay is a rapid, qualitative, competitive binding immunoassay for the determination of Opiates in urine at the cutoff level of 2000 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 indicated. Syntron's QuikPac II One Step Opiates Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiates and its metabolites.
    Device Description
    Syntron's QuikPac II One Step Opiate 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 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 2000 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
    K992990
    Device Name
    QUICKPAC II ONE STEP COCAINE TEST
    Manufacturer
    SYNTRON BIORESEARCH, INC.
    Date Cleared
    1999-09-20

    (13 days)

    Product Code
    DIO
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTRON BIORESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Syntron's QuikPac II One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the cutoff level of 300 ng/ml (NIDA screening cutoff is 300 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. Syntron's QuikPac II One Step Cocaine Test is not intended to monitor drug levels, but only to screen urines for the presence of Cocaine and its metabolites.
    Device Description
    Syntron's QuikPac II One Step Cocaine 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 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 300 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
    K992748
    Device Name
    DRUGCHECK X MULTIDRUG SCREENING DEVICE
    Manufacturer
    SYNTRON BIORESEARCH, INC.
    Date Cleared
    1999-09-02

    (17 days)

    Product Code
    DIO, DKZ, DPK, LCM, LDJ
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTRON BIORESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Syntron's DrugCheck X Multidrug Screening Device (the X may be replaced by 2. 3. 4. 5. 6. 7. or 8) is a holder for up to eight rapid, qualitative, competitive binding immunoassay strips for the detection of drugs of abuse in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DrugCheck X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP). The tests provide 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. Syntron's QuikStrip DrugCheck X Multidrug Screening Device is not intended to monitor drug levels, but only to screen urines for the presence of specific drugs of abuse and their metabolites.
    Device Description
    Syntron's DrugCheck X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, 6, 7, or 8) consists of two to eight (2-8) individual chromatographic absorbent devices 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 for each drug. 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, different for each drug, 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 specified by SAMHSA for GC/MS. 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. Each of the test strips in the holder functions independently and is read independently.
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    K Number
    K992207
    Device Name
    QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
    Manufacturer
    SYNTRON BIORESEARCH, INC.
    Date Cleared
    1999-07-22

    (22 days)

    Product Code
    DIO
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTRON BIORESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Syntron's QuikStrip One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the NIDA recommended cutoff of 300 ng/ml by GC/MS. (NIDA screening cutoff is 300 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 indicatedf. Syntron's QuikStrip One Step Cocaine Test is not intended to monitor drug levels, but only to screen urines for the presence of Cocaine and its metabolites.
    Device Description
    Syntron's QuikStrip One Step Cocaine 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 300 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
    K990325
    Device Name
    QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
    Manufacturer
    SYNTRON BIORESEARCH, INC.
    Date Cleared
    1999-06-24

    (142 days)

    Product Code
    DKZ, DIO, DIS, DJC, DJG, JXM, LCM, LDJ
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTRON BIORESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Syntron's QuikStrip DipScan X Multidrug Screening Device (the X is replaced by 2, 3, 4, 5, or 6) is a holder for up to six rapid, qualitative, competitive, binding immunoassay strips for the detection of drugs of abuse and their metabolites in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DipScan are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP). The tests provide only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Syntron's QuikStrip DipScan X Multidrug Screening Device is not intended to monitor drug levels, but only to screen for the presence of drugs of abuse and their metabolites.
    Device Description
    The sponsor, Syntron Bioresearch, Inc. (2774 Loker Ave. West, Carlsbad, California, 92008), has developed, manufactured, and tested under GMP/GLP guidelines a Strip Holder that will accommodate 2 to 6 of the company's cleared drugs of abuse strips for the qualitative detection of drugs of abuse and their metabolites in a quick, simple, easy to read, screening format. Test strips available for inclusion in the DipScan X also comprises Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates (300), and Phencyclidine (PCP). Syntron's QuikStrip DipScan X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, or 6) consists of two to six (2-6) individual test strips on which the drug or drug metabolites in the chromatographic absorbent device is immobilized on a porous membrane support for the limited antibody sites for each drug. As the test sample flows up the support the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex, different for each drug, competes with immobilized antigen conjugate in the test zone and will not produce a magenta color band when the drug is above the detection level specified by SAMHSA for GC/MS (Note the cutoff for opiates used in the opiate test strips was 300 ng/ml instead of the new cutoff of 2000 ng/ml for opiates and in the conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. Each of the test strips in the holder functions independently and is read independently. Test strips available for inclusion in the DipScan X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates (300), and Phencyclidine (PCP).
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    K Number
    K983113
    Device Name
    BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
    Manufacturer
    SYNTRON BIORESEARCH, INC.
    Date Cleared
    1998-11-18

    (75 days)

    Product Code
    CEP
    Regulation Number
    862.1485
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTRON BIORESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BeSure Plus OneStep Ovulation Home predicator test is a solid phase immunoassay in vitro diagnostic test kit. It is intended for over the counter use for the qualitative determination of leutinizing hormone (LH) in urine. This test kit is utilized to determine when the female body will ovulate, the most likely time for conception to occur.
    Device Description
    BeSure Plus OneStep Ovulation Prediction test is a Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine. BeSure Plus OneStep Ovulation Prediction test is based on comparative data with BeSure OneStep Ovulation Predictor test, a qualitative test for the determination of Luteinizing hormone currently being marketed by Syntron Bioresearch, Inc. The BeSure Plus OneStep Ovulation Prediction Test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. As the urine specimen is added to the reaction device, the gold-sol-anti-B LH antibody conjugate binds to the LH that exists in the urine specimen forming an antibody-antigen complex. This complex then migrates to the positive reaction zone and a LH antibody that is immobilized there by forming an antibody-antibody dye conjugate sandwich, which produces a rose-pink color band. In the absence of LH, there is no rose-pink color band that appears in the positive reaction zone. The remaining dye continues to flow up the absorbent device by passing through the positive reaction zone. This produces a rose-pink color band in the control reaction zone as immobilized antibody captures the unbound dye conjugate, demonstrating that the reagents and device are functioning correctly. This working principle can also be applied for the BeSure OneStep Ovulation Prediction test.
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    K Number
    K981292
    Device Name
    QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
    Manufacturer
    SYNTRON BIORESEARCH, INC.
    Date Cleared
    1998-05-26

    (47 days)

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

    SYNTRON BIORESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Syntron's QuikPac II One Step Phencyclidine (PCP) assay 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. Syntron's QuikPac II One Step 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
    Syntron's QuikPac II One Step Phencyclidine (PCP) 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 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 25 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
    K981019
    Device Name
    QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST
    Manufacturer
    SYNTRON BIORESEARCH, INC.
    Date Cleared
    1998-05-07

    (50 days)

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

    SYNTRON BIORESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Syntron's QuikStrip One Step Phencyclidine (PCP) assay 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. Syntron's QuikStrip One Step 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
    Syntron's QuikStrip One Step Phencyclidine (PCP) 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 25 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
    K980349
    Device Name
    QUICKPAC II ONE STEP BARBITURATE TEST
    Manufacturer
    SYNTRON BIORESEARCH, INC.
    Date Cleared
    1998-03-03

    (34 days)

    Product Code
    DIS
    Regulation Number
    862.3150
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTRON BIORESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Syntron's QuikPac II One Step Barbiturate assay is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturate in urine at the cutoff level of 200 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 indicated. Syntron's QuikPac II One Step Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites,
    Device Description
    Syntron's QuikPac II One Step Barbiturate 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 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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