Cleared Special

ROCHE ELECSYS ANTI-TG (K053426) - FDA 510(k) Clearance

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K053426 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
61d
Days
Class 2
Risk

K053426 is an FDA 510(k) clearance for the ROCHE ELECSYS ANTI-TG. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 7, 2006 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K053426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2005
Decision Date February 07, 2006
Days to Decision 61 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 104d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JZO System, Test, Thyroid 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 - JZO System, Test, Thyroid Autoantibody

All 91
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K053426.
ADVIA Centaur Anti-Thyroid Peroxidase II
K250250 · Siemens Healthcare Diagnostics, Inc. · Oct 2025
Access TPO Antibody
K240469 · Beckman Coulter, Inc. · Aug 2024
Access Thyroglobulin Antibody II
K213517 · Beckman Coulter, Inc. · Sep 2023
Elecsys Anti-Tg
K222610 · Roche Diagnostics · Sep 2023
Elecsys Anti-TSHR
K193313 · Roche Diagnostics · Feb 2020