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510(k) Data Aggregation
K Number
K040327Device Name
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
Manufacturer
Date Cleared
2004-04-19
(69 days)
Regulation Number
N/AWhy did this record match?
Product Code :
MVO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Accu-Stat™ Home Drug Test for Marijuana (THC) is a screening test for the rapid detection of THC and its metabolites in human urine at a cut-off level of 50 ng/ml. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of THC or its metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.
The Accu-Stat™ Home Drug Tcst for Marijuana and Cocaine (THC, COC) is a screening test for the rapid detection of THC and/or COC and its metabolites in human urine at a cut-off level of 50 ng/ml for THC and 300 ng/ml for COC. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of either THC, COC (or their metabolites) in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.
Device Description
The Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC), like other commercially available drug screening tests, qualitatively measures the presence or absence of THC and COC and their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of competitive binding. Drugs, which may be present in the urine specimen, compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Marijuana, if present in the urine specimen below 50 ng/ml, and Cocaine, if present in the urine specimen below 300 ng/ml, will not saturate the binding sites of the antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized marijuana or cocaine conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the marijuana level is above 50 ng/ml because it will saturate all the binding sites of anti-marijuana antibodies. The same holds true for cocaine if the level is above 300 ng/ml. It will saturate all the binding sites of anti-cocaine antibodies and therefore the colored line will not form in the test region. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of a drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.
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K Number
K030447Device Name
AT HOME DRUG CUP, MODEL 9150X
Manufacturer
Date Cleared
2003-04-14
(62 days)
Regulation Number
N/AWhy did this record match?
Product Code :
MVO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Amphetamine, MDA, Methamphetamine, MDMA , THC, Cocaine and Opiates.
Device Description
The At Home Drug Cup is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: amphetamine and MDA; 1000 ng/ml, methamphetamine and MDMA; 500 ng/ml, THC (or marijuana); 50 ng/ml, cocaine; 300 ng/ml, opiates; 300 ng/ml. This assay is intended for use in the home to assist in the prevention of drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory. The At Home Drug Cup, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / complexes.
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K Number
K014192Device Name
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET
Manufacturer
Date Cleared
2002-05-23
(153 days)
Product Code
Regulation Number
N/AWhy did this record match?
Product Code :
MVO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 ng/mL in urine to assist in screening of drugs of abuse samples at home and work place. For In vitro Diagnostic Use
Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use
Device Description
Life Sign® Home Drug Test (MET) is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.
Status Stik™ MET is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.
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K Number
K013778Device Name
PEACE OF MIND HOME DRUG TEST
Manufacturer
Date Cleared
2002-02-07
(86 days)
Regulation Number
N/AWhy did this record match?
Product Code :
MVO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Peace of Mind Home Drug Test is designed for the qualitative determination of five drugs of abuse and their metabolites in human urine at the following cut off concentrations:
| THC | 50ng/mL |
|-----------------|-----------|
| PCP | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of any of these drugs in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.
The Peace of Mind Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, PCP, Opiates, Cocaine and Methamphetamine at the following cut off concentrations:
| THC | 50ng/mL |
|-----------------|-----------|
| РСР | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of any of the five drugs. Confirmation, using GC/MS, of a possible drug result is recommended as the second step.
Device Description
The Peace of Mind Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
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K Number
K013409Device Name
AT HOME DRUG TEST, MODEL 9074
Manufacturer
Date Cleared
2001-12-06
(52 days)
Product Code
Regulation Number
N/AWhy did this record match?
Product Code :
MVO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection of the following drugs of abuse in urine: Cocaine.
Device Description
Immunoassay for the qualitative detection of benzoylecgonine in urine. The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: cocaine; 300 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory. The At Home Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drug and metabolites by visual color sandwich one step immunoassay technology.
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K Number
K013410Device Name
AT HOME DRUG TEST, MODEL 9064
Manufacturer
Date Cleared
2001-12-06
(52 days)
Product Code
Regulation Number
N/AWhy did this record match?
Product Code :
MVO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection/presence of the following drugs of abuse in urine: Amphetamines.
Device Description
Immunoassay for the qualitative detection of Amphetamines in urine. The At Home Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drug and metabolites by visual color sandwich one step immunoassay technology.
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K Number
K013412Device Name
AT HOME DRUG TEST, MODEL 9069
Manufacturer
Date Cleared
2001-12-06
(52 days)
Product Code
Regulation Number
N/AWhy did this record match?
Product Code :
MVO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection of any of the following drugs of abuse in urine: Methamphetamine, MDMA.
Device Description
The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: Methamphetamine, MDMA; 500 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory.
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K Number
K010653Device Name
AT HOME DRUG TEST, MODEL 9068 T
Manufacturer
Date Cleared
2001-04-05
(31 days)
Product Code
Regulation Number
N/AWhy did this record match?
Product Code :
MVO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K010654Device Name
AT HOME DRUG TEST, MODEL 9078 T
Manufacturer
Date Cleared
2001-04-05
(31 days)
Product Code
Regulation Number
N/AWhy did this record match?
Product Code :
MVO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K010655Device Name
AT HOME DRUG TESTT, MODEL 9150 T
Manufacturer
Date Cleared
2001-04-05
(31 days)
Product Code
Regulation Number
N/AWhy did this record match?
Product Code :
MVO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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