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510(k) Data Aggregation
K Number
K020869Device Name
FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)
Manufacturer
WORLDWIDE MEDICAL CORP.
Date Cleared
2002-06-11
(85 days)
Product Code
DKZ
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The First Check® Home Drug Test for MDMA (Ecstasy) is a screening test for the rapid detection of MDMA and its metabolites in human urine at a cut-off level of 500 ng/ml. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of MDMA or its metabolites in a urine sample. Such information is beneficial to consumer efforts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
Device Description
The First Check® Home Drug Test for MDMA (Ecstasy), like other commercially available drug screening tests, qualitatively measures the presence or absence of MDMA and its metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug/antibody complexes.
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K Number
K993852Device Name
FIRST CHECK HOME DRUG TEST PANEL 4
Manufacturer
WORLDWIDE MEDICAL CORP.
Date Cleared
2000-11-29
(383 days)
Product Code
LAF, DIO, DJG, LDJ
Regulation Number
862.3610Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The First Check® Home Drug Fest Panel 4 is an educational sereening test for the rapid detection of marijuana, cocaine, morphine/opiates, methamphetamine and for their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL, 300ng/mL and 1,000ng/mL respectively. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the four drugs concorned parchib, was not information is beneficial to consumer offorts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
Device Description
The First Check® Home Drug Test Panel 4, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, cocaine, morphine/opiates, methamphetamine and/or their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug/antibody complexes.
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K Number
K993663Device Name
FIRST CHECK HOME DRUG TEST (THC)
Manufacturer
WORLDWIDE MEDICAL CORP.
Date Cleared
2000-06-23
(238 days)
Product Code
LDJ
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The First Check Home Drug Test (THC) is an educational screening test for the rapid detection of THC (and its metabolites) in human urine at a cut off for the rapid dececeion of the (antended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned a two seep process to provious concerning the presence of THC (and its parents, with information obliozing is beneficial to consumer metabolices) in a arine baspeable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
Device Description
The First Check® Home Drug Test (THC), like many commercially available drug screening tests, qualitatively measures the presence or absence of THC and its metabolites in urine using a one step rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug/antibody complexes. The cut-off concentration for THC is 50ng/mL.
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K Number
K994138Device Name
FIRST CHECK HOME DRUG TEST PANEL 3
Manufacturer
WORLDWIDE MEDICAL CORP.
Date Cleared
2000-06-23
(199 days)
Product Code
LDJ, DIO, LAF
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The First Check® Home Drug Test Panel 3 is an educational screening test for the rapid detection of marijuana, cocaine, methamphetamine and/or their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL and 1,000 ng/mL, respectively. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the three drugs listed above in a human urine sample. Such information is beneficial to consumer efforts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
Device Description
The First Check® Home Drug Test Panel 3, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, cocaine, methamphetamine and/or their metabolites in urine, using a one stee, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drog/anibody complexes. The cut-off concentration for THC is 50ng/mL. The out-off concentration for COC is 300ng/mL. The cut-off concentration four MET is 1,000ng/mL.
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K Number
K994139Device Name
FIRST CHECK HOME DRUG TEST PANEL 2
Manufacturer
WORLDWIDE MEDICAL CORP.
Date Cleared
2000-06-23
(199 days)
Product Code
LDJ, DIO
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The First Check® Home Drug Test Panel 2 is an educational screening test for the rapid detection of marijuana and cocaine and/or their metabolites in human urine at cut-off levels of 50ng/mL and 300ng/mL, respectively. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the two drugs listed above in a human urine sample. Such information is beneficial to consumer efforts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
Device Description
The First Check® Home Drug Test Panel 2, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, and cocaine, and/or their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug/antibody complexes. The cutoff concentration for THC is 50ng/mL. The cut-off concentration for COC is 300ng/mL.
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