Cleared Traditional

RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 (K121603) - FDA 510(k) Clearance

Class I Chemistry device.

K121603 · Randox Laboratories, Ltd. · Chemistry device
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Nov 2012
Decision
228d
Days
Class 1
Risk

K121603 is an FDA 510(k) clearance for the RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on November 20, 2012 after a review of 228 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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K121603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2012
Decision Date November 20, 2012
Days to Decision 228 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
140d slower than avg
Panel avg: 88d · This submission: 228d
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.