Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

NGL — Predicate Candidate Screening

23 FDA 510(k) clearances under this product code; the 50 most recent screened below.

40 daysmedian FDA review time

93 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K253567	Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurat	Healgen Scientific,, LLC	2025-12-23	36
K250803	Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug	Anhui Deepblue Medical Technological Co., Ltd.	2025-04-15	29
K250067	Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine	Guangzhou Decheng Biotechnology Co., Ltd.	2025-02-20	41
K242428	Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Te	Guangzhou Decheng Biotechnology Co., Ltd.	2025-02-06	175
K243365	Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Ac	Healgen Scientific,, LLC	2024-12-17	49
K243064	ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ET	Eterbio, Inc.	2024-11-20	54
K242802	CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test	Hangzhou Clongene Biotech Co., Ltd.	2024-11-08	52
K241869	BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA	Vivachek Biotech (Hangzhou) Co., Ltd.	2024-10-04	99
K241969	Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Pane	Qingdao Hightop Biotech Co., Ltd.	2024-08-14	40
K241741	SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fen	Guangzhou Wondfo Biotech Co., Ltd.	2024-07-16	29
K241100	Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl	Co-Innovation Biotech Co., Ltd.	2024-05-22	30
K240949	Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Heal	Healgen Scientific,, LLC	2024-05-13	35
K240686	Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurat	Healgen Scientific,, LLC	2024-04-12	31
K240654	SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Te	Safecare Biotech (Hangzhou) Co., Ltd.	2024-04-10	34
K240295	InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl	Instanosis, Inc.	2024-03-28	56
K234006	AllSource Drug Detector FenTest; AllSource Drug Detector Fen	Allsource Screening Solutions	2024-03-21	93
K240351	FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fent	Assure Tech., LLC	2024-03-06	30
K233417	AllTest Fentanyl Urine Test Cassette	Hangzhou AllTest Biotech Co., Ltd.	2023-10-26	16
K193480	BIOEASY Multi-Drug Test Cup	Shenzhen Bioeasy Biotechnology Co., Ltd.	2020-01-31	46
K190412	CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test	Hangzhou Clongene Biotech Co., Ltd.	2019-03-21	28
K181790	CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test	Hangzhou Clongene Biotech Co., Ltd.	2018-07-26	21
K100108	AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MD	Amedica Biotech, Inc.	2010-04-14	90
K082898	AMEDICA DRUG SCREEN TEST CUP	Amedica Biotech, Inc.	2008-12-19	80

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda