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510(k) Data Aggregation
K Number
K033566Device Name
MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
Manufacturer
RAPID DIAGNOSTICS, INC.
Date Cleared
2004-05-17
(187 days)
Product Code
DKZ, DIO, DIS, DJC, DJG, DJR, JXM, LCM, LDJ
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
RAPID DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbital], 300 ng/ml; benzodiazepine [oxazepam], 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and cannabinoid, 50 ng/ml).
The MICROMEDIC® Drugs of Abuse Panel Test is intended for use in a point-ofcare (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities. The MICROMEDIC® Drugs of Abuse Panel Test will provide a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or the Substance Abuse and Mental Health Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfics the criteria for workplace testing established under DOT and SAMHSA.
Device Description
The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine.
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K Number
K020716Device Name
RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
Manufacturer
RAPID DIAGNOSTICS, INC.
Date Cleared
2002-05-06
(62 days)
Product Code
DJG
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
RAPID DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rapid Opiates Test Card II is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Opiates and its metabolites in human urine specimens. The presence of Morphine in human urine above a cutoff level of 2,000ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
Device Description
The Rapid Drug tests are based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for antibody binding between drug conjugate and free drug which may be present in the urine specimen being tested.
When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibody-dye conjugate. When the amount of drug is equal or more than the cutoff level, it will prevent the binding of drug conjugate to the antibody. As a result, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result.
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K Number
K003809Device Name
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
Manufacturer
RAPID DIAGNOSTICS, INC.
Date Cleared
2001-04-20
(133 days)
Product Code
DKZ, DIO, DJC, DJG, JXM, LDJ
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
RAPID DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K981770Device Name
RAPIDHCG PREGNANCY TEST
Manufacturer
RAPID DIAGNOSTICS, INC.
Date Cleared
1998-06-05
(17 days)
Product Code
JHI
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
RAPID DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RapidHCG Pregnancy Test is a qualitative test that detects the presence of human Chorionic Gonadotropin (hCG) in human urine specimens. The test is a visual one step, in vitro assay. The test is intended for professional use to help diagnose pregnancy in hospital and clinical lab.
Device Description
The test is a visual one step, in vitro assay.
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