Cleared Traditional

K143026 - Audit MicroControls Linearity FD Unsatu...

K143026 is the FDA 510(k) clearance for Audit MicroControls Linearity FD Unsatu... by Aalto Scientific, Ltd.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K143026 · Aalto Scientific, Ltd. · Chemistry device
Download Printable Device Report (PDF)
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Nov 2014
Decision
31d
Days
Class 1
Risk

K143026 is an FDA 510(k) clearance for the Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on November 21, 2014 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 Aalto Scientific, Ltd. devices

Submission Details

510(k) Number K143026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2014
Decision Date November 21, 2014
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 274
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