Cleared Traditional

CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS (K936166) - FDA 510(k) Clearance

Class I Toxicology device.

K936166 · Medical Analysis Systems, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Jul 1994
Decision
203d
Days
Class 1
Risk

K936166 is an FDA 510(k) clearance for the CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on July 13, 1994 after a review of 203 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K936166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1993
Decision Date July 13, 1994
Days to Decision 203 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 87d · This submission: 203d
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 201
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K936166.
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
K080183 · Roche Diagnostics Corp. · Mar 2008
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
K062191 · Dade Behring, Inc. · Aug 2006
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
K052053 · Bio-Rad · Aug 2005
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
K042865 · Bio-Rad · Nov 2004
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
K041561 · Bio-Rad · Jul 2004
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454
K033366 · Bio-Rad · Dec 2003