Cleared Traditional

K020349 - ABBOTT AXSYM ANTI-THYROGLOBULIN

K020349 is an FDA 510(k) clearance for ABBOTT AXSYM ANTI-THYROGLOBULIN, manufactured by Axis-Shield Diagnostics, Ltd.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K020349 · Axis-Shield Diagnostics, Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
87d
Days
Class 2
Risk

K020349 is an FDA 510(k) clearance for the ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Axis-Shield Diagnostics, Ltd. (Dundee, Scotland, GB). The FDA issued a Cleared decision on May 2, 2002 after a review of 87 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 Axis-Shield Diagnostics, Ltd. devices

FDA 510(k) Submission Details - K020349

510(k) Number K020349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2002
Decision Date May 02, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 104d · This submission: 87d
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 K020349.
SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
K023593 · Quest Intl., Inc. · Feb 2003
ELECSYS ANTI-TG TEST SYSTEM
K020672 · Roche Diagnostics Corp. · Aug 2002
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS
K020348 · Axis-Shield Diagnostics, Ltd. · May 2002
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
K020687 · Axis-Shield Diagnostics, Ltd. · May 2002
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