510(k) Report

Devices descending from K973547

29 later devices reach Triage Statmeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220046Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11Shenzhen Superbio Technology Co., Ltd.202217—
+1K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.20191—
+1K080635MedtoxscanMedtox Diagnostics, Inc.200991
+1K041696Rapid ReaderAmerican Bio Medica Corp.20050—
+2K240124BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd.20242—
+2K231904Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardCo-Innovation Biotech Co., Ltd.20241—
+2K231698AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd.202311—
+2K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.20200—
+2K140665GenPrime Snap-Top Split Key CupGenprime, Inc.20140—
+2K130082Genprime Drugs of Abuse Reader SystemGenprime, Inc.20132—
+2K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc.20094—
+3K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…Healgen Scientific,, LLC20250—
+3K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek®…Guangzhou Decheng Biotechnology Co., Ltd.20250—
+3K241869BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™…Vivachek Biotech (Hangzhou) Co., Ltd.20240—
+3K241100Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test DipcardCo-Innovation Biotech Co., Ltd.20240—
+3K233417AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd.20239—
+3K221550Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited20230—
+3K220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited202311
+3K100023Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemMedtox Diagnostics, Inc.20100—
+4K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited20260—
+4K242802CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteHangzhou Clongene Biotech Co., Ltd.20240—
+4K241969Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®…Qingdao Hightop Biotech Co., Ltd.20241—
+4K241741SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test…Guangzhou Wondfo Biotech Co., Ltd.20240—
+4K240949Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl…Healgen Scientific,, LLC20240—
+4K240654SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.20240—
+4K240295InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)Instanosis, Inc.20240—
+4K234006AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl TestAllsource Screening Solutions20240—
+4K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)Assure Tech., LLC20240—
+5K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl…Eterbio, Inc.20240—