Cleared Traditional

K974181 - ACCUSIGN DOA 2

K974181 is an FDA 510(k) clearance for ACCUSIGN DOA 2, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K974181 · Princeton BioMeditech Corp. · Toxicology device
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Dec 1997
Decision
35d
Days
Class 2
Risk

K974181 is an FDA 510(k) clearance for the ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZ.... 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 December 11, 1997 after a review of 35 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

FDA 510(k) Submission Details - K974181

510(k) Number K974181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1997
Decision Date December 11, 1997
Days to Decision 35 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
52d faster than avg
Panel avg: 87d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXM Device Classification - Class 2, Special Controls

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 75
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K974181.
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
K983174 · Roche Diagnostic Systems, Inc. · Nov 1998
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
K982831 · OraSure Technologies, Inc. · Nov 1998
QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
K981687 · Phamatech · Jun 1998
CEDIA DAU BENZODIAZEPINE ASSAY
K962734 · Boehringer Mannheim Corp. · Dec 1996
ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY
K962672 · Princeton BioMeditech Corp. · Aug 1996
ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP
K961325 · Princeton BioMeditech Corp. · Jun 1996