Cleared Traditional

K222116 - Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) (FDA 510(k) Clearance)

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

K222116 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Jul 2023
Decision
360d
Days
Class 2
Risk

K222116 is an FDA 510(k) clearance for the Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3.... Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on July 13, 2023 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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. Elevated predicate reliance profile. 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 K222116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2022
Decision Date July 13, 2023
Days to Decision 360 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
272d slower than avg
Panel avg: 88d · This submission: 360d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 241
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K222116.
Atellica® IM TSH3-Ultra II (TSH3ULII)
K251543 · Siemens Healthcare Diagnostics, Inc. · Feb 2026
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)
K243570 · Siemens Healthcare Diagnostics · Apr 2025
Maverick Diagnostic System TC1000
K234091 · Genalyte, Inc. · Jul 2024
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
K233050 · Siemens Healthcare Diagnostics, Inc. · Apr 2024
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225 · Beckman Coulter, Inc. · Nov 2022