Cleared Traditional

K003291 - BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY

K003291 is an FDA 510(k) clearance for BAYER DIAGNOSTICS ACS:180 AND ADVIA CEN..., manufactured by Bayer Diagnostics Corp.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K003291 · Bayer Diagnostics Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Dec 2000
Decision
46d
Days
Class 2
Risk

K003291 is an FDA 510(k) clearance for the BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on December 5, 2000 after a review of 46 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 Diagnostics Corp. devices

FDA 510(k) Submission Details - K003291

510(k) Number K003291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2000
Decision Date December 05, 2000
Days to Decision 46 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
59d faster than avg
Panel avg: 105d · This submission: 46d
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 71
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K003291.
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
K012777 · Bayer Corp. · Oct 2001
ALPCO MILENIA ANTI-TG EIA
K011415 · American Laboratory Products Co., Ltd. · May 2001
ALPCO MILENIA ANTI-TPO ELISA
K011201 · American Laboratory Products Co., Ltd. · May 2001
VARELISA TG (THYROGLOBULIN) ANTIBODIES,
K003414 · Pharmacia & Upjohn Co. · Nov 2000
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
K000155 · Roche Diagnostics Corp. · May 2000
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
K000362 · Zeus Scientific, Inc. · Feb 2000