Cleared Traditional

K122291 - THERMO SCIENTIFIC MAS OMNI-CARDIO

K122291 is an FDA 510(k) clearance for THERMO SCIENTIFIC MAS OMNI-CARDIO, manufactured by Microgenics Corporation. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K122291 · Microgenics Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
31d
Days
Class 1
Risk

K122291 is an FDA 510(k) clearance for the THERMO SCIENTIFIC MAS OMNI-CARDIO. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on August 31, 2012 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Corporation devices

FDA 510(k) Submission Details - K122291

510(k) Number K122291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2012
Decision Date August 31, 2012
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 593
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