Cleared Traditional

K251543 - Atellica® IM TSH3-Ultra II (TSH3ULII) (FDA 510(k) Clearance)

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

K251543 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Feb 2026
Decision
262d
Days
Class 2
Risk

K251543 is an FDA 510(k) clearance for the Atellica® IM TSH3-Ultra II (TSH3ULII). 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 February 6, 2026 after a review of 262 days - an extended review cycle.

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. 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 K251543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2025
Decision Date February 06, 2026
Days to Decision 262 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
174d slower than avg
Panel avg: 88d · This submission: 262d
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 K251543.
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K222116 · Siemens Healthcare Diagnostics, Inc. · Jul 2023
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225 · Beckman Coulter, Inc. · Nov 2022