510(k) Report

Devices descending from K933052

25 later devices reach Abuscreen Online (R) for Amphetamines, Modified through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992918STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103IOraSure Technologies, Inc.200014—
+1K993208STC Methamphetamine Intercept Micro-Plate Eia, Model 1104IOraSure Technologies, Inc.200071
+1K983699Modification to Abuscreen Online for AmphetaminesRoche Diagnostic Systems, Inc.19982—
+2K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation20126—
+2K110446Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral Fluid Dat…Roche Diagnostics20111—
+2K101753Thermo Scientific Cedia Methamphetamine Oft AssayMicrogenics Corp.20111—
+2K093884Roche Fludi MethamphetamineRoche Diagnostics20110—
+2K083764Amphetamines IIRoche Diagnostics Corp.20101—
+2K063024Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral…Lin-Zhi International, Inc.20061—
+2K062242Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and ControlsLin-Zhi International, Inc.20063—
+2K033743Cozart Eia Amphetamines Oral Fluid Microplate KitCozart Bioscience, Ltd.20042—
+3K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc.20183—
+3K141748Rapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator…Biophor Diagnostics, Inc.20150—
+3K133047Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…Biophor Diagnostics, Inc.20140—
+3K131652Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc.20142—
+3K131653Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc.20140—
+3K132688Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZBiochemical Diagnostics, Inc.20131—
+3K130811Psychemedics Microplate Eia for AmphetaminePsychemedics Corp.20131—
+3K093664Amphetamines II AssayRoche Diagnostics Corp.20100—
+4K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd.20250—
+4K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation20210—
+4K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation20210—
+4K181305OralTox Oral fluid Drug TestPremier Biotech, Inc.20181—
+4K142293Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…Biophor Diagnostics, Inc.20150—
+5K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC20260—