Cleared Traditional

K250816 - ADVIA Centaur Anti-Thyroglobulin II (aTgII)

K250816 is an FDA 510(k) clearance for ADVIA Centaur Anti-Thyroglobulin II (aTgII), manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Immunology device with product code JNL cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K250816 · Siemens Healthcare Diagnostics, Inc. · Immunology device
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Dec 2025
Decision
261d
Days
Class 2
Risk

K250816 is an FDA 510(k) clearance for the ADVIA Centaur Anti-Thyroglobulin II (aTgII). Classified as Immunochemical, Thyroglobulin Autoantibody (product code JNL), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on December 4, 2025 after a review of 261 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K250816

510(k) Number K250816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2025
Decision Date December 04, 2025
Days to Decision 261 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 105d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JNL Device Classification - Class 2, Special Controls

Product Code JNL Immunochemical, Thyroglobulin Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
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 Immunology devices follow this clearance model.

Regulatory Peers - JNL Immunochemical, Thyroglobulin Autoantibody

All 15
Devices cleared under the same product code (JNL) and FDA review panel - the closest regulatory comparables to K250816.
Access Thyroglobulin Antibody II
K240996 · Beckman Coulter, Inc. · Jul 2024
ACCESS THYROGLOBULIN ANITBODY
K112933 · Beckman Coulter, Inc. · Dec 2011
IMMUNOCAP THYRLOBULIN IMMUNOCAP
K072661 · Phadia US, Inc. · Nov 2007
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
K062516 · Beckman Coulter, Inc. · Oct 2006
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
K971834 · Monobind · Jul 1997
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
K962341 · Hycor Biomedical, Inc. · Nov 1996