Cleared Traditional

K960664 - BARBITURATE SERUM TOX EIA ASSAY

K960664 is an FDA 510(k) clearance for BARBITURATE SERUM TOX EIA ASSAY, manufactured by Diagnostic Reagents, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K960664 · Diagnostic Reagents, Inc. · Toxicology device
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May 1996
Decision
80d
Days
Class 2
Risk

K960664 is an FDA 510(k) clearance for the BARBITURATE SERUM TOX EIA ASSAY. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 6, 1996 after a review of 80 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 Diagnostic Reagents, Inc. devices

FDA 510(k) Submission Details - K960664

510(k) Number K960664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1996
Decision Date May 06, 1996
Days to Decision 80 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
7d faster than avg
Panel avg: 87d · This submission: 80d
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 89
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K960664.
VERDICT BARBITURATES
K963529 · Editek, Inc. · Oct 1996
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 EIA ESSAY (MODIFICATION)
K955928 · Diagnostic Reagents, Inc. · Mar 1996
ACS PHENOBARBITAL
K953021 · Ciba Corning Diagnostics Corp. · Dec 1995
AXSYM BARBITURATES II U
K951253 · Abbott Laboratories · May 1995