Cleared Traditional

K945610 - ABUSIGN(TM) AMP

K945610 is an FDA 510(k) clearance for ABUSIGN(TM) AMP, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 149-day FDA review.

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

FDA 510(k) Submission Details - K945610

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
Combination Product No
PCCP Authorized No
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.

DKZ Device Classification - Class 2, Special Controls

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 140
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K945610.
AXSYM AMPHETAMINE/METHAMPHETAMINE II
K953115 · Abbott Laboratories · Oct 1995
AMPHETAMINES MICRO-PLATE EIA
K935573 · Solarcare Technologies Corp,Inc. · Jul 1995
CEDIA DAU AMPHETAMINES ASSAY
K951154 · Microgenics Corp. · May 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
ABUSIGN DOA4
K943439 · Princeton BioMeditech Corp. · Feb 1995