Cleared Special

K991082 - ACCUSIGN DOA2

K991082 is an FDA 510(k) clearance for ACCUSIGN DOA2, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Toxicology device with product code DIS cleared through the Special 510(k) pathway after a 20-day FDA review.

K991082 · Princeton BioMeditech Corp. · Toxicology device
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Apr 1999
Decision
20d
Days
Class 2
Risk

K991082 is an FDA 510(k) clearance for the ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA R.... Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on April 15, 1999 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K991082

510(k) Number K991082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1999
Decision Date April 15, 1999
Days to Decision 20 days
Submission Type Special
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
67d faster than avg
Panel avg: 87d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

DIS Device Classification - Class 2, Special Controls

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 74
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K991082.
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
K983698 · Roche Diagnostic Systems, Inc. · May 1999
ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR
K991018 · Princeton BioMeditech Corp. · Apr 1999
ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP
K991076 · Princeton BioMeditech Corp. · Apr 1999
ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
K991084 · Princeton BioMeditech Corp. · Apr 1999
AUTO-LYTE BARBITURATES EIA
K982745 · OraSure Technologies, Inc. · Nov 1998
QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152
K982152 · Phamatech · Sep 1998