Cleared Traditional

Elecsys Tg II

K221890 · Roche Diagnostics · Immunology
Sep 2023
Decision
458d
Days
Class 2
Risk

About This 510(k) Submission

K221890 is an FDA 510(k) clearance for the Elecsys Tg II, a System, Test, Thyroglobulin (Class II — Special Controls, product code MSW), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 30, 2023, 458 days after receiving the submission on June 29, 2022. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K221890 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2022
Decision Date September 30, 2023
Days to Decision 458 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MSW — System, Test, Thyroglobulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

Similar Devices — MSW System, Test, Thyroglobulin

All 12
Atellica IM Thyroglobulin (Tg)
K242981 · Siemens Healthcare Diagnostics, Inc. · Jun 2025
Access Thyroglobulin
K240927 · Beckman Coulter, Inc. · Jun 2024
Access Thyroglobulin
K241423 · Beckman Coulter, Inc. · Jun 2024
Access Thyroglobulin
K220972 · Beckman Coulter, Inc. · Sep 2023
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
K031269 · Beckman Coulter, Inc. · May 2003
BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
K021057 · Brahms Diagnostica, LLC · Sep 2002