Cleared Traditional

K111964 - AUDIT MICROCV URINE/FLUIDS CHEMISTRY LI...

K111964 is the FDA 510(k) clearance for AUDIT MICROCV URINE/FLUIDS CHEMISTRY LI... by Aalto Scientific, Ltd.. It is a Class 1 Chemistry device (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

Submission Details

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
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 88d · This submission: 235d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 320
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K111964.
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1
K130963 · Bio-Rad Laboratories, Inc. · May 2013
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
K121603 · Randox Laboratories, Ltd. · Nov 2012
RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
K113720 · Randox Laboratories, Ltd. · Sep 2012
RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
K112337 · Randox Laboratories, Ltd. · Dec 2011
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
K110904 · Randox Laboratories, Ltd. · Sep 2011
ELECSYS PRECICONTROL VARIA 3
K111506 · Roche Diagnostics · Jul 2011