Cleared Traditional

K133550 - VALIDATE FERRITIN CALIBRATION VERIFICAT...

K133550 is the FDA 510(k) clearance for VALIDATE FERRITIN CALIBRATION VERIFICAT... by Maine Standards Company, LLC. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K133550 · Maine Standards Company, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
78d
Days
Class 1
Risk

K133550 is an FDA 510(k) clearance for the VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Maine Standards Company, LLC (Cumberland Foreside, US). The FDA issued a Cleared decision on February 5, 2014 after a review of 78 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 Maine Standards Company, LLC devices

Submission Details

510(k) Number K133550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2013
Decision Date February 05, 2014
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
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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