Cleared Traditional

K092749 - MAS AND MINI-TROL PTH CONTROL

K092749 is the FDA 510(k) clearance for MAS AND MINI-TROL PTH CONTROL by Microgenics Corporation. It is a Class 1 Immunology device (product code JJX) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K092749 · Microgenics Corporation · Immunology device
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Dec 2009
Decision
86d
Days
Class 1
Risk

K092749 is an FDA 510(k) clearance for the MAS AND MINI-TROL PTH CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on December 3, 2009 after a review of 86 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K092749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2009
Decision Date December 03, 2009
Days to Decision 86 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 104d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 371
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