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Found 7 results
510(k) Data Aggregation
K Number
K142293Device Name
Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls
Manufacturer
BIOPHOR DIAGNOSTICS, INC.
Date Cleared
2015-09-18
(396 days)
Product Code
LAF, DLJ, LAS
Regulation Number
862.3610Why did this record match?
Applicant Name (Manufacturer) :
BIOPHOR DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RapidFRET Oral Fluid Assay for Methamphetamine is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for methamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.
The RapidFRET Oral Fluid Methamine Calibrators and RapidFRET Oral Fluid Methamphetamine Controls are intended for use only with appropriate RapidFRET Oral Fluid Assay products and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive controls are used to monitor laboratory systems, operators, precision. accuracy and assay conditions. For In Vitro Diagnostic Use Only.
Device Description
The RapidFRET Oral Fluid Assay for Methamphetamine is an In Vitro Diagnostic competitive immunoassay used to detect methamphetamine in human oral fluid. This is a ready-to-use homogenous system that involves energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug. The assay is based on competition between drug in the sample and drug labeled with the donor fluorophore for a fixed number of binding sites on the antibody reagent. When acceptor and donor fluorophores are brought into close proximity through a binding event, energy transfer occurs. The fluorescence resonance energy transfer (FRET) signal is measured at the wavelength of the acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff Calibrator is used to translate the sample measurement into a positive or negative result. Controls are used to establish and monitor precision and accuracy.
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K Number
K142129Device Name
RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
Manufacturer
BIOPHOR DIAGNOSTICS, INC.
Date Cleared
2015-07-24
(354 days)
Product Code
DIO, DIF, DLJ
Regulation Number
862.3250Why did this record match?
Applicant Name (Manufacturer) :
BIOPHOR DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RapidFRET Oral Fluid Assay for Cocaine is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for cocaine at 20 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay is calibrated with Cocaine and provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.
The RapidFRET Oral Fluid Cocaine Calibrator Set and RapidFRET Oral Fluid Cocaine Control Set are intended for use with the RapidFRET Oral Fluid Assay for Cocaine and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.
Device Description
The RapidFRET Oral Fluid Assay for Cocaine is an In Vitro Diagnostic competitive immunoassay used to detect cocaine in human oral fluid. This is a ready-to-use homogenous system that involves energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug. The assay is based on competition between drug in the sample and drug labeled with the donor fluorophore for a fixed number of binding sites on the antibody reagent. When acceptor and donor fluorophores are brought into close proximity through a binding event, energy transfer occurs. The fluorescence resonance energy transfer (FRET) signal is measured at the wavelength of the acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff Calibrator is used to translate the sample measurement into a positive or negative result. Controls are used to establish and monitor precision and accuracy.
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K Number
K141748Device Name
RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
Manufacturer
BIOPHOR DIAGNOSTICS, INC.
Date Cleared
2015-05-20
(324 days)
Product Code
DKZ, DLJ, LAS
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
BIOPHOR DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RapidFRET Oral Fluid Assay for Amphetamine is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for amphetamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.
The RapidFRET Oral Fluid Amphetamine Calibrator Set and RapidFRET Oral Fluid Amphetamine Control Set are intended for use only with the RapidFRET Oral Fluid Assay for Amphetamine and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.
Device Description
The RapidFRET Oral Fluid Assay for Amphetamine is an In Vitro Diagnostic competitive immunoassay used to detect amphetamine in human oral fluid. This is a ready-to-use homogenous system that involves energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug. The assay is based on competition between drug in the sample and drug labeled with the donor fluorophore for a fixed number of binding sites on the antibody reagent. When acceptor and donor fluorophores are brought into close proximity through a binding event, energy transfer occurs. The fluorescence resonance energy transfer (FRET) signal is measured at the wavelength of the acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff Calibrator is used to translate the sample measurement into a positive or negative result. Controls are used to establish and monitor precision and accuracy.
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K Number
K133047Device Name
RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
Manufacturer
BIOPHOR DIAGNOSTICS, INC.
Date Cleared
2014-12-18
(447 days)
Product Code
LAF, DIF, DLJ
Regulation Number
862.3610Why did this record match?
Applicant Name (Manufacturer) :
BIOPHOR DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RapidFRET Oral Fluid Assay for MDMA is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Methylenedioxymethamphetamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.
The RapidFRET Oral Fluid MDMA Calibrator Set and RapidFRET Oral Fluid MDMA Control Set are intended for use only with the RapidFRET Oral Fluid Assay for MDMA and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.
Device Description
The RapidFRET Oral Fluid Assay for MDMA is an In Vitro Diagnostic competitive immunoassay used to detect MDMA in human oral fluid. This is a ready-to-use homogenous system that involves energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug. The assay is based on competition between drug in the sample and drug labeled with the donor fluorophore for a fixed number of binding sites on the antibody reagent. When acceptor and donor fluorophores are brought into close proximity through a binding event, energy transfer occurs. The fluorescence resonance energy transfer (FRET) signal is measured at the wavelength of the acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff Calibrator is used to translate the sample measurement into a positive result. Controls are used to establish and monitor precision and accuracy.
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K Number
K133642Device Name
RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK
Manufacturer
BIOPHOR DIAGNOSTICS, INC.
Date Cleared
2014-01-24
(58 days)
Product Code
DJG, DIF, DKB
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
BIOPHOR DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RapidFRET Oral Fluid Assay for OPIATES is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Opiates at 40 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay is calibrated against Morphine. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.
The RapidFRET Oral Fluid Calibrator Set and RapidFRET Oral Fluid Control Set are intended for use only with the RapidFRET Oral Fluid Assay for OPIATES and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to translate the sample measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.
Device Description
The RapidFRET Oral Fluid Assay for Opiates is provided in an all liquid, ready to use format. Two reagents are provided included a drug specific reagent and a second competitive donor reagent. The kit is provided with reagents and microtiter plates. A Cutoff Calibrator is used to translate the sample measurement into a positive or negative result. Controls are used to establish and monitor precision and accuracy. Calibrators and controls are sold separately.
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K Number
K132096Device Name
RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR
Manufacturer
BIOPHOR DIAGNOSTICS, INC.
Date Cleared
2013-10-18
(102 days)
Product Code
LDJ, DIF, DKB
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
BIOPHOR DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RapidFRET Oral Fluid Assay for THC is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Tetrahydrocannabinol at 4 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.
The RapidFRET Oral Fluid THC Calibrator Set and RapidFRET Oral Fluid THC Control Set are intended for use only with theRapidFRET Oral Fluid Assay for THC and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.
Device Description
The RapidFRET Oral Fluid Assay for THC is an In Vitro Diagnostic competitive immunoassay used to detect THC in human oral fluid. This is a ready-to-use homogenous system that involves energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug. The assay is based on competition between drug in the sample and drug labeled with the donor fluorophore for a fixed number of binding sites on the antibody reagent. When acceptor and donor fluorophores are brought into close proximity through a binding event, energy transfer occurs. The fluorescence resonance energy transfer (FRET) signal is measured at the wavelength of the acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff Calibrator is used to translate the sample measurement into a positive or negative result. Controls are used to establish and monitor precision and accuracy.
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K Number
K122703Device Name
RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
Manufacturer
BIOPHOR DIAGNOSTICS, INC.
Date Cleared
2013-04-25
(233 days)
Product Code
LCM, DIF, DKB
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIOPHOR DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RapidFRET Oral Fluid Assay for PCP is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Phencyclidine at 10 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.
The RapidFRET Oral Fluid PCP Calibrator Set and RapidFRET Oral Fluid PCP Control Set are intended for use only with the RapidFRET Oral Fluid Assay for PCP and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.
Device Description
The RapidFRET Oral Fluid Assay for PCP is an In Vitro Diagnostic competitive immunoassay used to detect PCP in human oral fluid. This is a ready-to-use homogenous system that involves energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug. The assay is based on competition between drug in the sample and drug labeled with the donor fluorophore for a fixed number of binding sites on the antibody reagent. When acceptor and donor fluorophores are brought into close proximity through a binding event, energy transfer occurs. The fluorescence resonance energy transfer (FRET) signal is measured at the wavelength of the acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff Calibrator is used to translate the sample measurement into a positive or negative result. Controls are used to establish and monitor precision and accuracy. The assay is performed on the RapidFRET Integrated Workstation.
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