Cleared Traditional

K023592 - SERAQUEST ANTI-THYROGLOBULIN

K023592 is the FDA 510(k) clearance for SERAQUEST ANTI-THYROGLOBULIN by Quest Intl., Inc.. It is a Class 2 Immunology device (product code DDC) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K023592 · Quest Intl., Inc. · Immunology device
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Jan 2003
Decision
73d
Days
Class 2
Risk

K023592 is an FDA 510(k) clearance for the SERAQUEST ANTI-THYROGLOBULIN. Classified as Thyroglobulin, Antigen, Antiserum, Control (product code DDC), Class II - Special Controls.

Submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on January 6, 2003 after a review of 73 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 Quest Intl., Inc. devices

Submission Details

510(k) Number K023592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2002
Decision Date January 06, 2003
Days to Decision 73 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
31d faster than avg
Panel avg: 104d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDC Thyroglobulin, Antigen, Antiserum, Control
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 - DDC Thyroglobulin, Antigen, Antiserum, Control

Devices cleared under the same product code (DDC) and FDA review panel - the closest regulatory comparables to K023592.
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
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K930486 · Inova Diagnostics, Inc. · Mar 1993
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