Cleared Traditional

Elecsys Anti-TSHR

K193313 · Roche Diagnostics · Immunology
Feb 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K193313 is an FDA 510(k) clearance for the Elecsys Anti-TSHR, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Roche Diagnostics (Indianpolis, US). The FDA issued a Cleared decision on February 27, 2020, 90 days after receiving the submission on November 29, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K193313 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2019
Decision Date February 27, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZO — System, Test, Thyroid Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

Similar Devices — JZO System, Test, Thyroid Autoantibody

All 91
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
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
K151799 · Phadia AB · Mar 2016
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
K152061 · Siemens Healthcare Diagnostics, Inc. · Mar 2016