Cleared Traditional

K926068 - EMIT(R) II BARBITURATE ASSAY

K926068 is an FDA 510(k) clearance for EMIT II BARBITURATE ASSAY, manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K926068 · Syva Co. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
42d
Days
Class 2
Risk

K926068 is an FDA 510(k) clearance for the EMIT(R) II BARBITURATE ASSAY. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 12, 1993 after a review of 42 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.

FDA 510(k) Submission Details - K926068

510(k) Number K926068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date January 12, 1993
Days to Decision 42 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 87d · This submission: 42d
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 99
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K926068.
STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA
K934376 · Solarcare, Inc. · Dec 1993
MICROLINE SCREEN FOR BARBITURATES
K933480 · Drug Screening Systems, Inc. · Oct 1993
EMIT(R) D.A.U. BARBITURATE ASSAY
K931535 · Syva Co. · Jun 1993
BARBITURATE EIA TEST
K925491 · Diagnostic Reagents, Inc. · Dec 1992
BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL
K920525 · Biotrack, Inc. · Aug 1992
IL TEST BARBITURATE, 35289
K920417 · Instrumentation Laboratory CO · Apr 1992
K926068 · EMIT(R) II BARBITURATE ASSAY
Download PDF FDA Summary Syva Co.