Search Results
Found 7 results
510(k) Data Aggregation
K Number
K003687Device Name
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
Manufacturer
MEDTOX DIAGNOSTICS, INC.
Date Cleared
2000-12-22
(22 days)
Product Code
DKE, DIO, DJG, DKZ, LCM
Regulation Number
862.3870Why did this record match?
Product Code :
DKE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994405Device Name
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
Manufacturer
ALFA SCIENTIFIC DESIGNS, INC.
Date Cleared
2000-06-02
(157 days)
Product Code
DKE
Regulation Number
862.3870Why did this record match?
Product Code :
DKE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Instant-View Marijuana (THC) Urine Test (Cassette) is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect 11-nor-delta-9, THC-carboxylic acid (THC), a major metabolites of marijuana in human urine at a cutoff level of 50 ng/ml. It is intended for health care professional use only.
The test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
Device Description
This test is a one-step lateral flow chromatographic immunoassay.
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K Number
K992068Device Name
STATUS STIK, ACCUSIGN STIK
Manufacturer
PRINCETON BIOMEDITECH CORP.
Date Cleared
1999-07-06
(18 days)
Product Code
DKE, DIO, DJC, DJG, DKZ, LCM
Regulation Number
862.3870Why did this record match?
Product Code :
DKE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoassay for the qualitative detection of amphetamine or methamphetamine, opiates, evcaine metabolites, THC metabolites, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:
THC 11-nor-Δ9-9-carboxylic acid 50 ng/mL
OPI Morphine 300 ng/mL
COC Benzoylecgonine 300 ng/mL
AMP Amphetamine 1000 ng/mL
MET D-Methamphetamine 1000 ng/mL
PCP Phencyclidine 25 ng/mL
Device Description
Not Found
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K Number
K991751Device Name
STATUS CUP ACCUSIGN CUP
Manufacturer
PRINCETON BIOMEDITECH CORP.
Date Cleared
1999-06-18
(25 days)
Product Code
DKE, DIO, DJG, DKZ, LAG, LCM
Regulation Number
862.3870Why did this record match?
Product Code :
DKE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoassay for the qualitative detection of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:
| AMP | Amphetamine | 1000 ng/mL |
|-----|-----------------------------|------------|
| THC | 11-nor-A9-9-carboxylic acid | 50 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL |
| OPI | Morphine | 300 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
Device Description
Not Found
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K Number
K991078Device Name
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
Manufacturer
PRINCETON BIOMEDITECH CORP.
Date Cleared
1999-04-15
(20 days)
Product Code
DKE, DIO, DIS, DJG, DKN, DKZ, LCM, LFI
Regulation Number
862.3870Why did this record match?
Product Code :
DKE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines, barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.
Device Description
Not Found
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K Number
K983147Device Name
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
Manufacturer
PRINCETON BIOMEDITECH CORP.
Date Cleared
1998-09-28
(20 days)
Product Code
DKE, DIO, DIS, DJG, DKN, DKZ, LCM, LFI
Regulation Number
862.3870Why did this record match?
Product Code :
DKE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.
Device Description
AccuSign® DOA 8 (THC/OPI/COC/AMP/BZO/BAR/TCA/PCP) Rapid One-Step Drugs of Abuse Panel Test
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K Number
K982211Device Name
PROFILE-II MODEL 600582
Manufacturer
MEDTOX DIAGNOSTICS, INC.
Date Cleared
1998-07-29
(36 days)
Product Code
DKE, DIO, DJG, DKZ, LCM
Regulation Number
862.3870Why did this record match?
Product Code :
DKE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine. The test detects the major metabolites of these drugs at the following cut-off concentrations:
THC Tetrahydrocannabinol 50 ng/mL
COC Cocaine (Benzoylecgonine) 300 ng/mL
OPS Opiates (Codeine/Morphine) 300 ng/mL
AMP Amphetamine 1000 ng/mL
PCP Phencyclidine 25 ng/mL
This product is intended for use under medical supervision in hospitals, physician offices, health clinics and drug treatment/counseling centers. It is not for over-the-counter sale.
PROFILE-II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/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.
Device Description
PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine.
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