Cleared Traditional

K983501 - ACCUSIGN DOA 10

K983501 is an FDA 510(k) clearance for ACCUSIGN DOA 10, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Toxicology device with product code LAG cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K983501 · Princeton BioMeditech Corp. · Toxicology device
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Dec 1998
Decision
73d
Days
Class 2
Risk

K983501 is an FDA 510(k) clearance for the ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/T.... Classified as High Pressure Liquid Chromatography, Methamphetamine (product code LAG), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on December 18, 1998 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 - K983501

510(k) Number K983501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1998
Decision Date December 18, 1998
Days to Decision 73 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
14d faster than avg
Panel avg: 87d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAG Device Classification - Class 2, Special Controls

Product Code LAG High Pressure Liquid Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - LAG High Pressure Liquid Chromatography, Methamphetamine

Devices cleared under the same product code (LAG) and FDA review panel - the closest regulatory comparables to K983501.
RAPID TOX CUP
K073078 · American Bio Medica Corp. · May 2008
MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP
K062575 · Princeton BioMeditech Corp. · Nov 2007
ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/
K990786 · Princeton BioMeditech Corp. · Mar 1999