Cleared Traditional

ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI (K954571) - FDA 510(k) Clearance

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

K954571 · Princeton BioMeditech Corp. · Toxicology device
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Nov 1995
Decision
32d
Days
Class 2
Risk

K954571 is an FDA 510(k) clearance for the ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on November 3, 1995 after a review of 32 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 Princeton BioMeditech Corp. devices

Submission Details

510(k) Number K954571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date November 03, 1995
Days to Decision 32 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 87d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 45
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K954571.
ONTRAK TESTCUP-ER
K983388 · Roche Diagnostic Systems, Inc. · Nov 1998
IMMULITE COCAINE METABOLITE
K963918 · Diagnostic Products Corp. · Apr 1997
FRONTLINE COCAINE
K954496 · Boehringer Mannheim Corp. · Mar 1996
AXSYM COCAINE METABOLITE
K951289 · Abbott Laboratories · Aug 1995
EMIT IIC COCAINE METABOLITE ASSAY
K935323 · Syva Co. · Feb 1995
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
K944231 · Roche Diagnostic Systems, Inc. · Dec 1994