Cleared Traditional

K863388 - QUANTIMETRIX DRUG FREE SERUM CONTROL

K863388 is the FDA 510(k) clearance for QUANTIMETRIX DRUG FREE SERUM CONTROL by Quantimetrix Corp.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K863388 · Quantimetrix Corp. · Toxicology device
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Sep 1986
Decision
26d
Days
Class 1
Risk

K863388 is an FDA 510(k) clearance for the QUANTIMETRIX DRUG FREE SERUM 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 September 29, 1986 after a review of 26 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 K863388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date September 29, 1986
Days to Decision 26 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 87d · This submission: 26d
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 K863388.
ACA URINE DRUGS OF ABUSE CONTROL
K873539 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1987
CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL
K873037 · Diagnostic Products Corp. · Oct 1987
TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG
K870586 · Medical Analysis Systems, Inc. · Apr 1987
LYPHOCHEK URINE TOXICOLOGY CONTROL
K861970 · Bio-Rad · Aug 1986
THERACHEM, TDC THERAPEUTIC DRUG CONTROLS
K860919 · Fisher Scientific Co., LLC · Apr 1986
THERAPEUTIC DRUG (TDM) CALIBRATOR
K860097 · Instrumentation Laboratory CO · Feb 1986