Cleared Traditional

K041361 - RANDOX TRI LEVEL CARDIAC CONTROL

K041361 is an FDA 510(k) clearance for RANDOX TRI LEVEL CARDIAC CONTROL, 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 111-day FDA review.

K041361 · Randox Laboratories Limited · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
111d
Days
Class 1
Risk

K041361 is an FDA 510(k) clearance for the RANDOX TRI LEVEL CARDIAC CONTROL. 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 September 9, 2004 after a review of 111 days - within the typical 510(k) review window.

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 Randox Laboratories Limited devices

FDA 510(k) Submission Details - K041361

510(k) Number K041361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2004
Decision Date September 09, 2004
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
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 K041361.
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
K042324 · Bio-Rad · Oct 2004
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05
K042335 · Bio-Rad Laboratories, Inc. · Sep 2004
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
K042389 · Roche Diagnostics Corp. · Sep 2004
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)
K041812 · Roche Diagnostics Corp. · Jul 2004
TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS
K040459 · Biosite Incorporated · Jul 2004
RANDOX IMMUNOASSAY CONTROL
K040379 · Randox Laboratories, Ltd. · Jun 2004