Cleared Traditional

SEKURE Creatine Kinase Assay (K182702) - FDA 510(k) Clearance

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

K182702 · Sekisui Diagnostics P.E.I., Inc. · Chemistry device
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Apr 2019
Decision
202d
Days
Class 2
Risk

K182702 is an FDA 510(k) clearance for the SEKURE Creatine Kinase Assay. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Sekisui Diagnostics P.E.I., Inc. (Charlottetown,, CA). The FDA issued a Cleared decision on April 17, 2019 after a review of 202 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 Sekisui Diagnostics P.E.I., Inc. devices

Submission Details

510(k) Number K182702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2018
Decision Date April 17, 2019
Days to Decision 202 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 88d · This submission: 202d
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 59
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K182702.
Pointe Scientific Creatinine Kinase (CK) Reagent Set
K191296 · Medtest DX · Aug 2020
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
K160724 · Siemens Healthcare Diagnostics, Inc. · Sep 2016
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
K123977 · Randox Laboratories, Ltd. · Nov 2013
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
K043202 · Olympus America, Inc. · Dec 2004
CK
K983070 · Abbott Laboratories · Feb 1999
CREATINE KINASE (CK)
K981218 · Abbott Laboratories · May 1998