Cleared Traditional

ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS (K012777) - FDA 510(k) Clearance

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

K012777 · Bayer Corp. · Immunology device
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Oct 2001
Decision
63d
Days
Class 2
Risk

K012777 is an FDA 510(k) clearance for the ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on October 22, 2001 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bayer Corp. devices

Submission Details

510(k) Number K012777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2001
Decision Date October 22, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 104d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 91
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K012777.
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
Elecsys Anti-TSHR
K193313 · Roche Diagnostics · Feb 2020
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092 · Roche Diagnostics Corp. · Jul 2008