Cleared Traditional

K172201 - Atellica IM Folate Assay (FDA 510(k) Clearance)

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

K172201 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 2018
Decision
265d
Days
Class 2
Risk

K172201 is an FDA 510(k) clearance for the Atellica IM Folate Assay. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on April 12, 2018 after a review of 265 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1295 - 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 K172201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2017
Decision Date April 12, 2018
Days to Decision 265 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
177d slower than avg
Panel avg: 88d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
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.