Cleared Traditional

K182702 - SEKURE Creatine Kinase Assay

K182702 is an FDA 510(k) clearance for SEKURE Creatine Kinase Assay, manufactured by Sekisui Diagnostics P.E.I., Inc.. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K182702 · Sekisui Diagnostics P.E.I., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K182702

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.

CGS Device Classification - Class 2, Special Controls

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 107
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
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RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
K123977 · Randox Laboratories, Ltd. · Nov 2013
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
K083465 · Siemens Healthcare Diagnostics · Feb 2009
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
K081731 · Siemens Healthcare Diagnostics · Aug 2008
CREATINE KINASE LIQUID REAGENT, MODEL C519-440
K072548 · Teco Diagnostics · Apr 2008