Cleared Traditional

K123977 - RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR (FDA 510(k) Clearance)

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

K123977 · Randox Laboratories, Ltd. · Chemistry device
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Nov 2013
Decision
330d
Days
Class 2
Risk

K123977 is an FDA 510(k) clearance for the RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on November 21, 2013 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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. Elevated predicate reliance profile. 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 K123977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2012
Decision Date November 21, 2013
Days to Decision 330 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
242d slower than avg
Panel avg: 88d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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.