Cleared Traditional

K963529 - VERDICT BARBITURATES

K963529 is an FDA 510(k) clearance for VERDICT BARBITURATES, manufactured by Editek, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K963529 · Editek, Inc. · Toxicology device
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Oct 1996
Decision
56d
Days
Class 2
Risk

K963529 is an FDA 510(k) clearance for the VERDICT BARBITURATES. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Editek, Inc. (Burlington, US). The FDA issued a Cleared decision on October 30, 1996 after a review of 56 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. 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 Editek, Inc. devices

FDA 510(k) Submission Details - K963529

510(k) Number K963529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1996
Decision Date October 30, 1996
Days to Decision 56 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
31d faster than avg
Panel avg: 87d · This submission: 56d
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 87
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K963529.
QUICKPAC II ONE STEP BARBITURATE TEST
K980349 · Syntron Bioresearch, Inc. · Mar 1998
QUIKSTRIP ONE STEP BARBITURATE TEST
K974712 · Syntron Bioresearch, Inc. · Feb 1998
ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST
K973047 · Drial Consultants, Inc. · Oct 1997
ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY
K962669 · Princeton BioMeditech Corp. · Aug 1996
ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD
K961010 · Princeton BioMeditech Corp. · Jun 1996
BARBITURATE SERUM TOX EIA ASSAY
K960664 · Diagnostic Reagents, Inc. · May 1996