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510(k) Data Aggregation
K Number
K121231Device Name
IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
Manufacturer
Date Cleared
2012-07-30
(97 days)
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
IND NDIAGNOSTIC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IND Drug Home Test is a rapid chromatographic immunoassay multi-panel or single drug test for the qualitative detection of one or more of the following drugs: Amphetamine, Methamphetamine, Cocaine, Marijuana, and Morphine in human urine. It is intended for overthe-counter use.
The test is intended for over-the counter (OTC) use as the first step in a two step process to provide consumers with information concerning the presence of the above stated drugs or metabolites in a urine sample. The test provides only preliminary test results. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC/MS (Gas Chromatography / Mass Spectrometry) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Device Description
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