Cleared Traditional

K103656 - THERMO SCIENTIFIC MAS R DOA TOTAL

K103656 is an FDA 510(k) clearance for THERMO SCIENTIFIC MAS R DOA TOTAL, manufactured by Microgenics Corporation. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K103656 · Microgenics Corporation · Toxicology device
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Mar 2011
Decision
99d
Days
Class 1
Risk

K103656 is an FDA 510(k) clearance for the THERMO SCIENTIFIC MAS R DOA TOTAL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on March 24, 2011 after a review of 99 days - within the typical 510(k) review window.

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 Microgenics Corporation devices

FDA 510(k) Submission Details - K103656

510(k) Number K103656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2010
Decision Date March 24, 2011
Days to Decision 99 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 87d · This submission: 99d
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 K103656.
DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
K121122 · Biochemical Diagnostic, Inc. · Jul 2012
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
K121143 · Bio-Rad Laboratories · May 2012
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
K120504 · Bio-Rad Laboratories, Inc. · Mar 2012
LIQUICHEK OPIATE CONTROL
K093577 · Bio-Rad Laboratories · Mar 2010
MAS TOX CONTROL
K080085 · Thermo Fisher Scientific · Apr 2008
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