Cleared Traditional

K153646 - SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

K153646 is an FDA 510(k) clearance for SAFECARE Urine Test Amphetamine, manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K153646 · Safecare Biotech (Hangzhou) Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
88d
Days
Class 2
Risk

K153646 is an FDA 510(k) clearance for the SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine .... Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 18, 2016 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Safecare Biotech (Hangzhou) Co., Ltd. devices

FDA 510(k) Submission Details - K153646

510(k) Number K153646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date March 18, 2016
Days to Decision 88 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 87d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIO Device Classification - Class 2, Special Controls

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 Toxicology devices follow this clearance model.

Regulatory Consultant

Lsi International
Joe Shia

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 131
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K153646.
MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
K162395 · Mp Biomedicals, LLC · Jun 2017
Quest Diagnostics HairCheck-DT (Cocaine)
K152232 · Quest Diagnostics Incorporated · Nov 2016
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
K161214 · Guangzhou Wondfo Biotech Co., Ltd. · Jun 2016
RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
K142129 · Biophor Diagnostics, Inc. · Jul 2015
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set
K150925 · Immunalysis Corporation · Jun 2015
First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
K142353 · W.H.P.M., Inc. · Oct 2014