Cleared Traditional

K843818 - HUMAN SERUM ANTICONVULSANT DRUG CONTROL

K843818 is the FDA 510(k) clearance for HUMAN SERUM ANTICONVULSANT DRUG CONTROL by Quantimetrix Corp.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K843818 · Quantimetrix Corp. · Toxicology device
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Oct 1984
Decision
32d
Days
Class 1
Risk

K843818 is an FDA 510(k) clearance for the HUMAN SERUM ANTICONVULSANT DRUG CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on October 30, 1984 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 Quantimetrix Corp. devices

Submission Details

510(k) Number K843818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1984
Decision Date October 30, 1984
Days to Decision 32 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 87d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 110
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K843818.
LYPHOCHEK DRUG FREE SERUM(HUMAN)
K852414 · Bio-Rad · Jul 1985
EMIT IMIPRAMINE/DESIPRAMINE CONTROL
K844945 · Syva Co. · Jan 1985
EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL
K844946 · Syva Co. · Jan 1985
COBAS FP TDM CONTROLS
K843913 · Roche Diagnostic Systems, Inc. · Oct 1984
EMIT 700 CONTROL SET B
K843508 · Syva Co. · Sep 1984
EMIT 700 CONTROL SET A
K843161 · Syva Co. · Aug 1984