Cleared Traditional

K023593 - SERAQUEST ANTI-THYROID PEROXIDASE (TPO)

K023593 is the FDA 510(k) clearance for SERAQUEST ANTI-THYROID PEROXIDASE (TPO) by Quest Intl., Inc.. It is a Class 2 Immunology device (product code JZO) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K023593 · Quest Intl., Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
104d
Days
Class 2
Risk

K023593 is an FDA 510(k) clearance for the SERAQUEST ANTI-THYROID PEROXIDASE (TPO). Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on February 6, 2003 after a review of 104 days - within the typical 510(k) review window.

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 Quest Intl., Inc. devices

Submission Details

510(k) Number K023593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2002
Decision Date February 06, 2003
Days to Decision 104 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
At panel average
Panel avg: 104d · This submission: 104d
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 41
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K023593.
ROCHE ELECSYS ANTI-TG
K053426 · Roche Diagnostics Corp. · Feb 2006
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
ELECSYS ANTI-TG TEST SYSTEM
K020672 · Roche Diagnostics Corp. · Aug 2002
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
K012777 · Bayer Corp. · Oct 2001
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
K000155 · Roche Diagnostics Corp. · May 2000