Cleared Traditional

K132156 - RANDOX CSF CONTROLS LEVELS 2 AND 3

K132156 is an FDA 510(k) clearance for RANDOX CSF CONTROLS LEVELS 2 AND 3, manufactured by Randox Laboratories, Ltd.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K132156 · Randox Laboratories, Ltd. · Chemistry device
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Oct 2013
Decision
104d
Days
Class 1
Risk

K132156 is an FDA 510(k) clearance for the RANDOX CSF CONTROLS LEVELS 2 AND 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 October 23, 2013 after a review of 104 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, Ltd. devices

FDA 510(k) Submission Details - K132156

510(k) Number K132156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2013
Decision Date October 23, 2013
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
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 593
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