Cleared Traditional

K032842 - MICROGENICS CYCLOSPORINE CONTROL KIT

K032842 is an FDA 510(k) clearance for MICROGENICS CYCLOSPORINE CONTROL KIT, manufactured by Microgenics Corp.. The device is a Class 1 Chemistry device with product code LAS cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K032842 · Microgenics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
36d
Days
Class 1
Risk

K032842 is an FDA 510(k) clearance for the MICROGENICS CYCLOSPORINE CONTROL KIT. 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 October 17, 2003 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - the FDA in vitro diagnostics and chemistry 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

FDA 510(k) Submission Details - K032842

510(k) Number K032842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2003
Decision Date October 17, 2003
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

LAS Device Classification - Class 1, General Controls

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.

Regulatory Peers - LAS Drug Specific Control Materials

All 69
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