Cleared Traditional

K110534 - RANDOX LIQUID CARDIAC CONTROL LEVELS 1

K110534 is an FDA 510(k) clearance for RANDOX LIQUID CARDIAC CONTROL LEVELS 1, manufactured by Randox Laboratories Limited. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K110534 · Randox Laboratories Limited · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
332d
Days
Class 1
Risk

K110534 is an FDA 510(k) clearance for the RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on January 23, 2012 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Randox Laboratories Limited devices

FDA 510(k) Submission Details - K110534

510(k) Number K110534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2011
Decision Date January 23, 2012
Days to Decision 332 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
244d slower than avg
Panel avg: 88d · This submission: 332d
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 516
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K110534.
AUDIT MICROLQ SPINAL FLUID CONTROL
K112742 · Aalto Scientific, Ltd. · Jun 2012
AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
K111964 · Aalto Scientific, Ltd. · Mar 2012
AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
K112705 · Aalto Scientific, Ltd. · Jan 2012
RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
K112337 · Randox Laboratories, Ltd. · Dec 2011
IT/IF CONTROL
K101863 · Sebia · Nov 2011
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
K110904 · Randox Laboratories, Ltd. · Sep 2011