Cleared Traditional

K112143 - AUDIT MICROCV T-UPTAKE LINEARITY

K112143 is an FDA 510(k) clearance for AUDIT MICROCV T-UPTAKE LINEARITY, manufactured by Aalto Scientific, Ltd.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K112143 · Aalto Scientific, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
189d
Days
Class 1
Risk

K112143 is an FDA 510(k) clearance for the AUDIT MICROCV T-UPTAKE LINEARITY. 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 January 31, 2012 after a review of 189 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 - K112143

510(k) Number K112143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2011
Decision Date January 31, 2012
Days to Decision 189 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
101d slower than avg
Panel avg: 88d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

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 426
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K112143.
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
K121084 · Siemens Healthcare Diagnostics, Inc. · May 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
K112653 · ACON Laboratories, Inc. · Apr 2012
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...
K111938 · Immunodiagnostic Systems , Ltd. · Feb 2012
GLUCOSE METER-CHECK SOLUTION FOR INFOPIA
K113764 · Bionostics, Inc. · Jan 2012
VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT
K113524 · Maine Standards Co. · Jan 2012
GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT
K112352 · Bionostics, Inc. · Dec 2011