Cleared Traditional

K130337 - RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 (FDA 510(k) Clearance)

Class I Immunology device.

K130337 · Randox Laboratories Limited · Immunology device
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Jun 2013
Decision
128d
Days
Class 1
Risk

K130337 is an FDA 510(k) clearance for the RANDOX SPECIALITY CONTROL (I) 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 June 19, 2013 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K130337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2013
Decision Date June 19, 2013
Days to Decision 128 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 104d · This submission: 128d
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.