Cleared Traditional

ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator (K160724) - FDA 510(k) Clearance

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

K160724 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Sep 2016
Decision
175d
Days
Class 2
Risk

K160724 is an FDA 510(k) clearance for the ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibr.... Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on September 7, 2016 after a review of 175 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 Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K160724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2016
Decision Date September 07, 2016
Days to Decision 175 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
87d slower than avg
Panel avg: 88d · This submission: 175d
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 K160724.
Pointe Scientific Creatinine Kinase (CK) Reagent Set
K191296 · Medtest DX · Aug 2020
SEKURE Creatine Kinase Assay
K182702 · Sekisui Diagnostics P.E.I., Inc. · Apr 2019
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