Cleared Traditional

K160724 - ADVIA Chemistry Creatine Kinase (CK_L) ...

K160724 is an FDA 510(k) clearance for ADVIA Chemistry Creatine Kinase (CK_L) ..., manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 175-day FDA review.

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

FDA 510(k) Submission Details - K160724

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.

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 K160724.
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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