Chrysalis Intelligence · Product Codes · NFT

NFT · Test, Amphetamine, Over The Counter

Clinical Toxicology · 23 clearances · 11 unique sponsors

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Device class
Class II
Regulation 862.3100
Total clearances
23
2020-05-27 → 2026-07-17
Last 12 months
7
Unique sponsors
11
Classification details
Medical specialty
Clinical Toxicology
Review panel
TX
Regulation number
862.3100
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Vivachek Biotech (Hangzhou) Co., Ltd. 4 2 2026-05-22
Hangzhou AllTest Biotech Co., Ltd. 4 0 2025-04-04
Guangzhou Wondfo Biotech Co., Ltd. 3 2 2026-04-28
Assure Tech., LLC 3 1 2026-07-17
Aicheck Biotech, Inc. 2 0 2024-10-01
Safecare Biotech (Hangzhou) Co., Ltd. 2 0 2021-03-24
Advin Biotech, Inc. 1 1 2025-10-09
Healstone Biotech, Inc. 1 0 2022-08-30
Hangzhou Clongene Biotech Co., Ltd. 1 0 2025-08-27
WEBEST Biotech,, LLC 1 1 2026-03-09
Qingdao Hightop Biotech Co., Ltd. 1 0 2022-05-05
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
80307 CPT — Medium Drug screen, presumptive, single-step method (e.g., immunoassay); amphetamine testing
80323 CPT — Medium Amphetamine; any method
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-17 K261984 Assure Tech., LLC AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup
2026-05-22 K261280 Vivachek Biotech (Hangzhou) Co., Ltd. BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel
2026-04-28 K260065 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx
2026-03-09 K260355 WEBEST Biotech,, LLC Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
2025-11-18 K252550 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
2025-10-09 K252867 Advin Biotech, Inc. VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup
2025-09-12 K252554 Vivachek Biotech (Hangzhou) Co., Ltd. Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
2025-08-27 K252118 Hangzhou Clongene Biotech Co., Ltd. CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
2025-08-15 K252259 Assure Tech., LLC AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
2025-04-04 K250727 Hangzhou AllTest Biotech Co., Ltd. AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
2025-02-27 K244043 Hangzhou AllTest Biotech Co., Ltd. AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
2025-02-07 K243996 Assure Tech., LLC AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup
2024-10-01 K242498 Aicheck Biotech, Inc. Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC
2024-09-27 K242540 Hangzhou AllTest Biotech Co., Ltd. AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel
2024-08-14 K242077 Aicheck Biotech, Inc. PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
2024-06-17 K241428 Hangzhou AllTest Biotech Co., Ltd. AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup
2023-11-02 K233062 Vivachek Biotech (Hangzhou) Co., Ltd. BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
2022-11-10 K222667 Vivachek Biotech (Hangzhou) Co., Ltd. Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
2022-08-30 K221871 Healstone Biotech, Inc. Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
2022-05-05 K220685 Qingdao Hightop Biotech Co., Ltd. HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
2021-03-24 K202453 Safecare Biotech (Hangzhou) Co., Ltd. SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
2020-09-25 K202567 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
2020-05-27 K201120 Safecare Biotech (Hangzhou) Co., Ltd. SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence