Cleared Traditional

K961010 - ACCUSIGN DOA 3

K961010 is an FDA 510(k) clearance for ACCUSIGN DOA 3, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K961010 · Princeton BioMeditech Corp. · Toxicology device
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Jun 1996
Decision
107d
Days
Class 2
Risk

K961010 is an FDA 510(k) clearance for the ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR.... 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 June 28, 1996 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 - K961010

510(k) Number K961010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1996
Decision Date June 28, 1996
Days to Decision 107 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
20d slower than avg
Panel avg: 87d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K961010.
QUICKPAC II ONE STEP BARBITURATE TEST
K980349 · Syntron Bioresearch, Inc. · Mar 1998
QUIKSTRIP ONE STEP BARBITURATE TEST
K974712 · Syntron Bioresearch, Inc. · Feb 1998
ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY
K962669 · Princeton BioMeditech Corp. · Aug 1996
BARBITURATE SERUM TOX EIA ASSAY
K960664 · Diagnostic Reagents, Inc. · May 1996
BARBITURATE EIA ESSAY (MODIFICATION)
K955928 · Diagnostic Reagents, Inc. · Mar 1996
ACS PHENOBARBITAL
K953021 · Ciba Corning Diagnostics Corp. · Dec 1995