Cleared Traditional

K040327 - ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)

K040327 · Accu-Stat Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
69d
Days
-
Risk

K040327 is an FDA 510(k) clearance for the ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (TH.... Classified as Kit, Test, Multiple, Drugs Of Abuse, Over The Counter (product code MVO).

Submitted by Accu-Stat Diagnostics, Inc. (Lake Forest, US). The FDA issued a Cleared decision on April 19, 2004 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. 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.

FDA 510(k) Submission Details - K040327

510(k) Number K040327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2004
Decision Date April 19, 2004
Days to Decision 69 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
18d faster than avg
Panel avg: 87d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

MVO Device Classification - Class 0,

Product Code MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Device Class -

Regulatory Peers - MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

All 17
Devices cleared under the same product code (MVO) and FDA review panel - the closest regulatory comparables to K040327.
AT HOME DRUG CUP, MODEL 9150X
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LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET
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PEACE OF MIND HOME DRUG TEST
K013778 · Advantage Diagnostics Corp. · Feb 2002
AT HOME DRUG TEST, MODEL 9074
K013409 · Phamatech, Inc. · Dec 2001
AT HOME DRUG TEST, MODEL 9064
K013410 · Phamatech, Inc. · Dec 2001
AT HOME DRUG TEST, MODEL 9069
K013412 · Phamatech, Inc. · Dec 2001
K040327 · ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
Download PDF FDA Summary Accu-Stat Diagnostics…