Cleared Traditional

K193313 - Elecsys Anti-TSHR

K193313 is an FDA 510(k) clearance for Elecsys Anti-TSHR, manufactured by Roche Diagnostics. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

K193313 is an FDA 510(k) clearance for the Elecsys Anti-TSHR. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 27, 2020 after a review of 90 days - within the typical 510(k) review window.

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 Roche Diagnostics devices

FDA 510(k) Submission Details - K193313

510(k) Number K193313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 104d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZO Device Classification - Class 2, Special Controls

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 61
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K193313.
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
THYRETAIN TM TSI REPORTER BIOASSAY
K092229 · Diagnostic Hybrids, Inc. · May 2010