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) (FDA 510(k) Clearance)

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

K161954 · Siemens Healthcare Diagnostics · Chemistry device
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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.

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Submission Details

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
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.

Device Classification

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 161
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