Cleared Traditional

K843679 - HUMAN SERUM CARDIOACTIVE DRUG CONTROL

K843679 is the FDA 510(k) clearance for HUMAN SERUM CARDIOACTIVE DRUG CONTROL by Quantimetrix Corp.. It is a Class 1 Chemistry device (product code DIF) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K843679 · Quantimetrix Corp. · Chemistry device
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Oct 1984
Decision
17d
Days
Class 1
Risk

K843679 is an FDA 510(k) clearance for the HUMAN SERUM CARDIOACTIVE DRUG CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Quantimetrix Corp. (Mchenry, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 17 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.

View all Quantimetrix Corp. devices

Submission Details

510(k) Number K843679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1984
Decision Date October 05, 1984
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
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 K843679.
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
COMA TOXICOLOGY CONTROL
K841439 · American Dade · May 1984