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510(k) Data Aggregation
K Number
K973269Device Name
QUIKSTRIP ONE STEP BENZODIAZEPINE TEST
Manufacturer
DRIAL CONSULTANTS, INC.
Date Cleared
1998-02-25
(180 days)
Product Code
JXM
Regulation Number
862.3170Why did this record match?
Applicant Name (Manufacturer) :
DRIAL CONSULTANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Syntron's QuikStrip One Step 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 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 QuikStrip One Step Benzodiazepine Test is not intended to monitor drug levels, but only to screen urines for the presence of Benzodiazepine and its metabolites:
Device Description
Syntron's QuikStrip One Step 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
K973326Device Name
QUIKPAC II ONE STEP BENZODIAZEPINE TEST
Manufacturer
DRIAL CONSULTANTS, INC.
Date Cleared
1998-02-24
(173 days)
Product Code
JXM
Regulation Number
862.3170Why did this record match?
Applicant Name (Manufacturer) :
DRIAL CONSULTANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Syntron's QuikPac II One Step 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 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 Benzodiazepine Test is not intended to monitor drug levels, but only to screen urines for the presence of Benzodiazepine and its metabolites.
Device Description
Syntron's QuikPac II One Step 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 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
K973047Device Name
ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST
Manufacturer
DRIAL CONSULTANTS, INC.
Date Cleared
1997-10-02
(48 days)
Product Code
DIS
Regulation Number
862.3150Why did this record match?
Applicant Name (Manufacturer) :
DRIAL CONSULTANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TCPI's One Step™ Urine Drug of Abuse Barbiturate Test is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturates 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. TCPI's One Step™ Urine Drug of Abuse: Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites.
Device Description
TCPI's One Step™ Urine Drug of Abuse: 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 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 cutoff 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
K972059Device Name
QUIKPAC II ONE STEP COCAINE TEST
Manufacturer
DRIAL CONSULTANTS, INC.
Date Cleared
1997-08-28
(87 days)
Product Code
DIO
Regulation Number
862.3250Why did this record match?
Applicant Name (Manufacturer) :
DRIAL CONSULTANTS, 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 150 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 150 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
K972571Device Name
QUIKSTRIP ONE STEP OPIATES TEST
Manufacturer
DRIAL CONSULTANTS, INC.
Date Cleared
1997-08-20
(41 days)
Product Code
DJG
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
DRIAL CONSULTANTS, 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 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 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 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
K972405Device Name
QUIKPAC II ONE STEP OPIATE TEST
Manufacturer
DRIAL CONSULTANTS, INC.
Date Cleared
1997-08-08
(43 days)
Product Code
DJG
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
DRIAL CONSULTANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Syntron's QuikPac II One Step Opiate assay is a rapid, qualitative, competitive binding immunoassay for the determination of Opiate in urine at the cutoff level of 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 Opiate Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiate 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 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
K971926Device Name
QUIKSTRIP ONE STEP COCAINE TEST
Manufacturer
DRIAL CONSULTANTS, INC.
Date Cleared
1997-07-14
(48 days)
Product Code
DIO
Regulation Number
862.3250Why did this record match?
Applicant Name (Manufacturer) :
DRIAL CONSULTANTS, 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 150 mg/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 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 150 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
K970395Device Name
QUIKSTRIP ONE STEP METHAMPHETAMINE
Manufacturer
DRIAL CONSULTANTS, INC.
Date Cleared
1997-06-26
(143 days)
Product Code
DKZ, LAF
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
DRIAL CONSULTANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Syntron's QuikStrip One Step Methamphetamine assay is a rapid, qualitative, competitive binding immunoassay for the determination of methamphetamine in urine. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GCMS). 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 One Step Methamphetamine Test is not intended to monitor drug levels, but only screen urines for the presence of methamphetamine and its metabolites.
Device Description
Syntron's QuikStrip One Step Methamphetamine 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
K971218Device Name
QUIKSTRIP ONE STEP AMPHETAMINE TEST
Manufacturer
DRIAL CONSULTANTS, INC.
Date Cleared
1997-05-30
(58 days)
Product Code
DKZ
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
DRIAL CONSULTANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Syntron's QuikStrip One Step Amphetamine assay is a rapid, gualitative, competitive binding immunoassay for the determination of qualitative, components ble test provides only preliminary data which Amplietamine firmed by other methods such as gas should be commy/mass spectrophotometry (GC/MS). Clinical chroilatograppyrinass opesional judgment should be applied to any considerations and professarioularly when preliminary positive drug of abuse teated. Syntron's QuikStrip One Step Amphetamine Test is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.
Device Description
Syntron's QuikStrip One Step 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
K971109Device Name
QUIKPAC II ONE STEP AMPHETAMINE TEST
Manufacturer
DRIAL CONSULTANTS, INC.
Date Cleared
1997-05-14
(49 days)
Product Code
DKZ
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
DRIAL CONSULTANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for professional medical/forensic screening of urine.
Device Description
The trade name of the device is QuikPac II One Step Amphetamine Test having a designated common name of Amphetamine Test System and a classification as a class II device per 21 CFR paragraph 862.3100. Syntron's QuikPac II One Step 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 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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