Cleared Traditional

K962353 - ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)

K962353 is an FDA 510(k) clearance for ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP), manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K962353 · Princeton BioMeditech Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
62d
Days
Class 2
Risk

K962353 is an FDA 510(k) clearance for the ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP). Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on August 19, 1996 after a review of 62 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

FDA 510(k) Submission Details - K962353

510(k) Number K962353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1996
Decision Date August 19, 1996
Days to Decision 62 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 87d · This submission: 62d
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 Peers - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 95
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K962353.
STC COCAINE METABOLITE MICRO-PLATE EIA
K973651 · OraSure Technologies, Inc. · Jan 1998
RAPID DRUG SCREEN
K964900 · American Bio Medica Corp. · Apr 1997
IMMULITE COCAINE METABOLITE
K963918 · Diagnostic Products Corp. · Apr 1997
COCAINE METABOLITE EIA TEST
K960187 · Diagnostic Reagents, Inc. · Apr 1996
FRONTLINE COCAINE
K954496 · Boehringer Mannheim Corp. · Mar 1996
ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI
K954571 · Princeton BioMeditech Corp. · Nov 1995