Cleared Traditional

K161954 - Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)

K161954 is an FDA 510(k) clearance for Atellica Solution, manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K161954 · Siemens Healthcare Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
234d
Days
Class 2
Risk

K161954 is an FDA 510(k) clearance for the Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellic.... Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on March 9, 2017 after a review of 234 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 devices

FDA 510(k) Submission Details - K161954

510(k) Number K161954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2016
Decision Date March 09, 2017
Days to Decision 234 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
146d slower than avg
Panel avg: 88d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGS Device Classification - Class 2, Special Controls

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 133
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K161954.
Stat Profile Prime Plus Analyzer System
K180428 · Nova Biomedical Corporation · Aug 2018
Synermed ISE Reagents
K181201 · Infrared Laboratory Systems, LLC (Dba Synermed) · Jul 2018
SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
K171476 · Awareness Technology, Inc. · Feb 2018
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
K161837 · Beckman Coulter, Inc. · Dec 2016
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
K160225 · Instrumentation Laboratory CO · Dec 2016
i-STAT Alinity System with i-STAT Sodium test
K153357 · Abbott Point of Care, Inc. · Jul 2016