Elecsys Anti-TSHR— 510(k) K193313

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K193313 for Elecsys Anti-TSHR, Substantially Equivalent on 2020-02-27. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 2019-11-29
Decision date: 2020-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K193313

K-number listed on FDA's recall record

Z-1009-2026 — The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.Class II·Ongoing·Roche Diagnostics Operations, Inc.·20251121

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193313.

Data sourced from openFDA. This site is unofficial and independent of the FDA.