Cleared Traditional

K061617 - FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST

K061617 is an FDA 510(k) clearance for FORSURE ONE STEP DIP & READ (X) DRUG SC..., manufactured by Tianjin New Bay Bioresearch Co., Ltd.. The device is a Class 2 Chemistry device with product code DKZ cleared through the Traditional 510(k) pathway after a 166-day FDA review.

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

FDA 510(k) Submission Details - K061617

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.

DKZ Device Classification - Class 2, Special Controls

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 185
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K061617.
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
K093114 · Microgenics Corp. · May 2010
AMPHETAMINES II
K083764 · Roche Diagnostics Corp. · Feb 2010
MEDTOXSCAN
K080635 · Medtox Diagnostics, Inc. · Feb 2009
VITROS CHEMISTRY PRODUCTS AMPH REAGENT
K062077 · Ortho-Clinical Diagnostics, Inc. · Nov 2006
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS
K063024 · Lin-Zhi International, Inc. · Oct 2006
RAPIDTOX
K053359 · American Bio Medica Corp. · May 2006