Cleared Traditional

ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP (K945610) - FDA 510(k) Clearance

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

K945610 · Princeton BioMeditech Corp. · Toxicology device
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Apr 1995
Decision
149d
Days
Class 2
Risk

K945610 is an FDA 510(k) clearance for the ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on April 13, 1995 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Princeton BioMeditech Corp. devices

Submission Details

510(k) Number K945610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1994
Decision Date April 13, 1995
Days to Decision 149 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
62d slower than avg
Panel avg: 87d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 76
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K945610.
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION
K972891 · Roche Diagnostic Systems, Inc. · Oct 1997
ONTRAK TESTCUP AMPHETAMINES
K962411 · Roche Diagnostic Systems, Inc. · Oct 1996
AXSYM AMPHETAMINE/METHAMPHETAMINE II
K953115 · Abbott Laboratories · Oct 1995
URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950135 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1995
EMIT(R) IIC AMPHETAMINE ASSAY
K935352 · Syva Co. · Feb 1995
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
K935042 · Roche Diagnostic Systems, Inc. · Jan 1994