Cleared Traditional

THERMO SCIENTIFIC MAS R DOA TOTAL (K103656) - FDA 510(k) Clearance

Class I Toxicology device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 87d · This submission: 99d
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 K103656.
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K892380 · Baxter Healthcare Corp · Feb 1990
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K883210 · Syva Co. · Sep 1988
DADE TDM CONTROL
K883190 · Baxter Healthcare Corp · Sep 1988
EMIT HVA CONTROL KIT
K881944 · Syva Co. · Jul 1988