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510(k) Data Aggregation
K Number
K203647Device Name
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
Manufacturer
Immunalysis Corporation
Date Cleared
2021-12-22
(373 days)
Product Code
LAF
Regulation Number
862.3610Why did this record match?
Product Code :
LAF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For In Vitro Diagnostic Use.
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 50 ng/mL in neat oral fluid collected by Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of methamphetamine in human oral fluid with clinical analyzers. This assay is calibrated against d-methamphetamine.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
Device Description
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an in-vitro test to detect the presence of methamphetamine in human oral fluid samples collected by Quantisal or Quantisal II Oral Fluid Collection Device.
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K Number
K210212Device Name
Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
Manufacturer
Psychemedics Corporation
Date Cleared
2021-12-15
(322 days)
Product Code
LAF, DKZ
Regulation Number
862.3610Why did this record match?
Product Code :
LAF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Psychemedics homogeneous enzyme immunoassay (HEIA) for amphetamines in hair is an enzyme immunoassay system for the preliminary qualitative detection of methamphetamine in human head and body hair using a methamphetamine calibrator at 3 ng methamphetamine/10 mg hair or 5 ng methamphetamine/10 mg hair for the purpose of identifying methamphetamine use, and for the preliminary qualitative detection of amphetamine in human head and body hair using an amphetamine calibrator at 3 ng amphetamine/10 mg hair for the purpose of identifying amphetamine use.
This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not for sale to anyone. The Psychemedics HEIA for amphetamines in hair provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS) is the preferred confirmatory method.
Device Description
The test consists of two parts; a pre-analytical hair treatment procedure (to extract amphetamines from the solid hair matrix to a measurable liquid matrix) and the screening assay, the Psychemedics Amphetamines HEIA. The screening portion of the test system is based on competition for antibody binding sites between drug in the measurable liquid matrix and drug-labeled recombinant glucose-6-phosphate dehydrogenase (G6PDH). As the antibody binds labeled G6PDH, enzyme activity decreases. In the presence of drug, enzyme activity increases in direct proportion to the drug concentration. Active enzyme reduces nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose 6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically.
The Psychemedics Amphetamines HEIA consists of reagents R1 (anti-methamphetamine monoclonal antibody with substrate) and R2 (methamphetamine labeled recombinant G6PDH) for the detection of methamphetamine, and reagents R1 (anti-amphetamine monoclonal antibody with substrate) and R2 (amphetamine labeled recombinant G6PDH) for the detection of amphetamine.
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K Number
K201442Device Name
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
Manufacturer
Diatron Group
Date Cleared
2020-07-31
(60 days)
Product Code
LAF
Regulation Number
862.3610Why did this record match?
Product Code :
LAF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is intended for the qualitative determination of d-methamphetamine in human urine at a cutoff value of 500 ng/mL. The system was calibrated with d-methamphetamine. The assay provides a rapid screening procedure for determining the presence of d-methamphetamine in urine.
The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Device Description
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is intended for the qualitative determination of methamphetamine in human urine, at a cutoff value of 500 ng/mL.
The assay is designed for laboratory use by trained professionals with various automated clinical chemistry analyzers.
This assay provides a rapid screening procedure for assessing the presence of d-methamphetamine in urine. The assay provides only a preliminary analytical result reported as a positive or negative. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. The analyzer photometer reads the absorbance at 340mm at time intervals dictated by the Methamphetamine application stored in the analyzer memory, and the change in absorbance is calculated automatically.
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K Number
K170222Device Name
Rapid Tox Cup II
Manufacturer
AMERICAN BIO MEDICA CORP.
Date Cleared
2017-08-15
(202 days)
Product Code
LAF, DIO, DIS, DJG, DJR, DKZ, JXM, LCM, LDJ, LFG
Regulation Number
862.3610Why did this record match?
Product Code :
LAF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rapid TOX Cup II is an in vitro diagnostic drugs of abuse testing device intended for use in the qualitative detection of the following drugs of abuse testing in a human urine specimen: Amphetamines, Barbiturates (Butalbital), Benzodiazepines (Oxazepam), Buprenorphine, Cocaine, MDMA (Methylenedioxymethamphetamine), Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Marijuana, Tricyclic Antidepressants. The test is intended for over-the-counter use.
Device Description
Rapid TOX Cup II is a drug test that can detect 1 to 13 drugs in human urine. Rapid TOX Cup II is collection cup with a temperature strip attached. It contains an insert with one or more test strips in the insert. Each test strip can test for up to 4 different drugs. The test is for over-the-counter or professional use. Rapid TOX CUP II is a first step in a 2-step process. The test provides information about the presence of certain drugs in urine. The second step in the process is more specific testing by a laboratory.
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K Number
K153693Device Name
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
Manufacturer
IMMUNALYSIS CORPORATION
Date Cleared
2016-03-18
(86 days)
Product Code
LAF, DKB, DKZ
Regulation Number
862.3610Why did this record match?
Product Code :
LAF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Immunalysis Methamphetamine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 500ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Methamphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Methamphetamine. This in-vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures.
The Immunalysis Methamphetamine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC-MS or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine, PCP and Oxazepan. The calibrators are designed for prescription use with immunoassays.
Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Methamphetamine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Methamphetamine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
All of the Immunalysis Multi-Drug Calibrators are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture.
The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles.
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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?
Product Code :
LAF
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
K150096Device Name
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
Manufacturer
HEALGEN SCIENTIFIC LLC
Date Cleared
2015-03-04
(43 days)
Product Code
LAF, LCM
Regulation Number
862.3610Why did this record match?
Product Code :
LAF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Healgen MDMA (Ecstasy) Test is an immunochromatographic assay for the qualitative determination of Methylenedioxymethamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result: GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.
Healgen Phencyclidine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a Cut-Off concentration of 25 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.
Device Description
Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine Test are immunochromatographic assays for Methylenedioxymethamphetamine and Phencyclidine. Each assay test is a lateral flow system for the qualitative detection of Methylenedioxymethamphetamine and Phencyclidine (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package Each test device is sealed with a desiccant in an aluminum pouch. insert.
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K Number
K150162Device Name
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
Manufacturer
W.H.P.M., Inc.
Date Cleared
2015-02-26
(31 days)
Product Code
LAF, DJG, JXM
Regulation Number
862.3610Why did this record match?
Product Code :
LAF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Oxazepam , Methamphetamine, and Morphine in human urine at cut-off concentrations of 300 ng/mL, and 2000 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.
The tests may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for oxazepam in urine. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
Device Description
First Sign™ Drug of Abuse Tests are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of Oxazepam , Methamphetamine , and Morphine in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of DipCards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
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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?
Product Code :
LAF
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
K131652Device Name
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
Manufacturer
Lin-Zhi International, Inc.
Date Cleared
2014-03-21
(289 days)
Product Code
LAF, DLJ, LAS
Regulation Number
862.3610Why did this record match?
Product Code :
LAF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LZI Oral Fluid Methamphetamine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of d-methamphetamine in neat human oral fluid, collected into the LZI Oral Fluid Collector, at the cutoff value 50 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS and LCMS or (2) permitting laboratories to establish quality control procedures.
The LZI Oral Fluid Methamphetamine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid Methamphetamine Enzyme Immunoassay at the cutoff value 50 ng/mL.
The LZI Oral Fluid Methamphetamine Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid Methamphetamine Enzyme Immunoassay at the cutoff value of 50 ng/mL.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography|mass spectrometry (GC|MS or LC|MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Device Description
The LZI Oral Fluid Methamphetamine assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, methamphetamine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound methamphetamine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The LZI Oral Fluid Methamphetamine Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The R1 solution contains mouse monoclonal anti-methamphetamine antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-o-phosphate dehydrogenase (G6PDH) labeled with methamphetamine in buffer with sodium azide (0.09%) as preservative.
The LZI Oral Fluid Methamphetamine Enzyme Immunoassay calibrators and controls designated for use at the 50 ng/mL cutoffs contain 0, 20, 37.5, 50, 62.5, 100, and 140 ng/mL of dmethamphetamine in human oral fluid with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
The LZI Oral Fluid Collector is a 50 mL polypropylene collection tube. It is a non-sterile centrifuge tube with a screw-on cap and printed graduations (United Lab Plastics, Catalog#UP2262).
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