Cleared Traditional

K061617 - FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K061617 · Tianjin New Bay Bioresearch Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
166d
Days
Class 2
Risk

K061617 is an FDA 510(k) clearance for the FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Tianjin New Bay Bioresearch Co., Ltd. (Carlsbad, US). The FDA issued a Cleared decision on November 22, 2006 after a review of 166 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3100 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Tianjin New Bay Bioresearch Co., Ltd. devices

Submission Details

510(k) Number K061617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2006
Decision Date November 22, 2006
Days to Decision 166 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 88d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 224
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K061617.
DRI Ecstasy Plus Assay
K240670 · Microgenics Corporation · Oct 2024
AllTest Multi-Drug Rapid Test Cup
K233019 · Hangzhou AllTest Biotech Co., Ltd. · Dec 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
K231137 · Xenta Biomedical Science Co., Ltd. · May 2023
Quidel Triage® TOX Drug Screen, 94600
K200363 · Quidel Cardiovascular, Inc. · Mar 2020
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
K191099 · Atlas Medical · Oct 2019
Quidel Triage TOX Drug Screen, 94600
K182719 · Quidel Cardiovascular, Inc. · Jun 2019