Cleared Traditional

Elecsys Tg II (K221890) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K221890 is an FDA 510(k) clearance for the Elecsys Tg II. Classified as System, Test, Thyroglobulin (product code MSW), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 30, 2023 after a review of 458 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

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Submission Details

510(k) Number K221890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
354d slower than avg
Panel avg: 104d · This submission: 458d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSW System, Test, Thyroglobulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 - MSW System, Test, Thyroglobulin

All 8
Devices cleared under the same product code (MSW) and FDA review panel - the closest regulatory comparables to K221890.
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
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
K002905 · Beckman Coulter, Inc. · Oct 2000