Cleared Traditional

K152085 - Liquid CO2-2 (LCO2-2) (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152085 · Randox Laboratories, Ltd. · Chemistry device
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Feb 2016
Decision
212d
Days
Class 2
Risk

K152085 is an FDA 510(k) clearance for the Liquid CO2-2 (LCO2-2). Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Ardmore, GB). The FDA issued a Cleared decision on February 24, 2016 after a review of 212 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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 K152085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2015
Decision Date February 24, 2016
Days to Decision 212 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
124d slower than avg
Panel avg: 88d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHS Enzymatic, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.