Cleared Traditional

K020672 - ELECSYS ANTI-TG TEST SYSTEM

K020672 is an FDA 510(k) clearance for ELECSYS ANTI-TG TEST SYSTEM, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K020672 · Roche Diagnostics Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Aug 2002
Decision
157d
Days
Class 2
Risk

K020672 is an FDA 510(k) clearance for the ELECSYS ANTI-TG TEST SYSTEM. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 5, 2002 after a review of 157 days - an extended review 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: 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 Corp. devices

FDA 510(k) Submission Details - K020672

510(k) Number K020672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2002
Decision Date August 05, 2002
Days to Decision 157 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
52d slower than avg
Panel avg: 105d · This submission: 157d
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 67
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K020672.
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
K051890 · Roche Diagnostics Corp. · Aug 2005
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
K033977 · Zeus Scientific, Inc. · Mar 2004
SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
K023593 · Quest Intl., Inc. · Feb 2003
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS
K020348 · Axis-Shield Diagnostics, Ltd. · May 2002
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
K020349 · Axis-Shield Diagnostics, Ltd. · May 2002
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
K020687 · Axis-Shield Diagnostics, Ltd. · May 2002