Cleared Traditional

ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP (K961325) - FDA 510(k) Clearance

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

K961325 · Princeton BioMeditech Corp. · Toxicology device
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Jun 1996
Decision
65d
Days
Class 2
Risk

K961325 is an FDA 510(k) clearance for the ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, B.... Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on June 12, 1996 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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 K961325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1996
Decision Date June 12, 1996
Days to Decision 65 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
22d faster than avg
Panel avg: 87d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 50
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K961325.
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
K983702 · Roche Diagnostic Systems, Inc. · Feb 1999
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
K983174 · Roche Diagnostic Systems, Inc. · Nov 1998
CEDIA DAU BENZODIAZEPINE ASSAY
K962734 · Boehringer Mannheim Corp. · Dec 1996
AXSYM BENZODIAZEPINES
K951286 · Abbott Laboratories · May 1995
AXSYM CANNABINOIDS
K951288 · Abbott Laboratories · May 1995
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE
K950427 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1995