Cleared Traditional

K111964 - AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY

K111964 is an FDA 510(k) clearance for AUDIT MICROCV URINE/FLUIDS CHEMISTRY LI..., manufactured by Aalto Scientific, Ltd.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K111964 · Aalto Scientific, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
235d
Days
Class 1
Risk

K111964 is an FDA 510(k) clearance for the AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on March 2, 2012 after a review of 235 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Aalto Scientific, Ltd. devices

FDA 510(k) Submission Details - K111964

510(k) Number K111964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2011
Decision Date March 02, 2012
Days to Decision 235 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
147d slower than avg
Panel avg: 88d · This submission: 235d
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 572
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