Cleared Traditional

K051074 - MAS IMMUNOSUPPRESSANT CONTROLS (FDA 510(k) Clearance)

Class I Toxicology device.

K051074 · Microgenics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
40d
Days
Class 1
Risk

K051074 is an FDA 510(k) clearance for the MAS IMMUNOSUPPRESSANT CONTROLS. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on June 6, 2005 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 Microgenics Corp. devices

Submission Details

510(k) Number K051074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2005
Decision Date June 06, 2005
Days to Decision 40 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
47d faster than avg
Panel avg: 87d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAS Drug Specific 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.