Cleared Traditional

K823746 - ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG

K823746 is an FDA 510(k) clearance for ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG, manufactured by Syva Co.. The device is a Class 1 Chemistry device with product code DIF cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K823746 · Syva Co. · Chemistry device
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Jan 1983
Decision
30d
Days
Class 1
Risk

K823746 is an FDA 510(k) clearance for the ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1983 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - the FDA in vitro diagnostics and chemistry 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 - K823746

510(k) Number K823746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1982
Decision Date January 12, 1983
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 89d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIF Drug Mixture Control Materials

All 201
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K823746.
CONTOX DURG CONTROL
K830492 · Kaulson Laboratories, Inc. · Mar 1983
CONTOX DRUG SCREEN CONTROL
K830494 · Kaulson Laboratories, Inc. · Mar 1983
CONTOX HEAVYMETALS CONTROL
K830234 · Kaulson Laboratories, Inc. · Feb 1983
THERAPEUTIC DRUG CONTROL
K822777 · Icl Scientific · Oct 1982
ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX
K821975 · Ortho Diagnostic Systems, Inc. · Aug 1982
Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED
K821950 · Travenol Laboratories, S.A. · Jul 1982
K823746 · ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG
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