Cleared Traditional

K841439 - COMA TOXICOLOGY CONTROL

K841439 is an FDA 510(k) clearance for COMA TOXICOLOGY CONTROL, manufactured by American Dade. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K841439 · American Dade · Toxicology device
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May 1984
Decision
40d
Days
Class 1
Risk

K841439 is an FDA 510(k) clearance for the COMA TOXICOLOGY CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on May 16, 1984 after a review of 40 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 American Dade devices

FDA 510(k) Submission Details - K841439

510(k) Number K841439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1984
Decision Date May 16, 1984
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 87d · This submission: 40d
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 175
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K841439.
HUMAN SERUM CARDIOACTIVE DRUG CONTROL
K843679 · Quantimetrix Corp. · Oct 1984
EMIT 700 CONTROL SET B
K843508 · Syva Co. · Sep 1984
EMIT 700 CONTROL SET A
K843161 · Syva Co. · Aug 1984
LYPHOCHEK THERAPEUTIC DRUG CONTROL
K833794 · Bio-Rad · Jan 1984
TRICYCLIC ANTIDEPRESSANTS
K831736 · Utak Laboratories, Inc. · Jul 1983
AMOXAPINE 8-HYDRO-XYAMOXAPINE
K831734 · Utak Laboratories, Inc. · Jul 1983