Cleared Traditional

K951223 - CK-MB (NAC-ACT)

K951223 is the FDA 510(k) clearance for CK-MB (NAC-ACT) by Randox Laboratories, Ltd.. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K951223 · Randox Laboratories, Ltd. · Chemistry device
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Dec 1995
Decision
281d
Days
Class 2
Risk

K951223 is an FDA 510(k) clearance for the CK-MB (NAC-ACT). Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on December 26, 1995 after a review of 281 days - an extended review cycle.

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. 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 K951223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1995
Decision Date December 26, 1995
Days to Decision 281 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 88d · This submission: 281d
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.

Regulatory Peers - CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

All 99
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K951223.
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K981218 · Abbott Laboratories · May 1998
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CREATINE KINASE (CK)
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CREATINE KINASE REAGENT SYSTEM
K952745 · Medical Diagnostic Technologies, Inc. · Aug 1995
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K952646 · Instrumentation Laboratory CO · Aug 1995
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K942773 · Diagnostic Chemicals , Ltd. · Aug 1994