Cleared Traditional

K161494 - Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

K161494 is an FDA 510(k) clearance for Atellica CH Creatinine_2 (Crea_2), manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K161494 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Nov 2016
Decision
167d
Days
Class 2
Risk

K161494 is an FDA 510(k) clearance for the Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL). Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on November 15, 2016 after a review of 167 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 - K161494

510(k) Number K161494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2016
Decision Date November 15, 2016
Days to Decision 167 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
79d slower than avg
Panel avg: 88d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGX Device Classification - Class 2, Special Controls

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 142
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K161494.
Atellica® CH Creatinine_3 (Crea3)
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Creatinine2
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K132638 · Siemens Healthcare Diagnostics, Inc. · Jan 2014
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K133728 · Siemens Healthcare Diagnostics, Inc. · Jan 2014
EASYRA CREATININE REAGENT
K123586 · Medica Corporation · May 2013