Cleared Traditional

K032134 - TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT

K032134 is an FDA 510(k) clearance for TSH RECEPTOR ANTIBODY (TRAB) COATED TUB..., manufactured by Kronus Market Development Associates, Inc.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K032134 · Kronus Market Development Associates, Inc. · Immunology device
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Sep 2003
Decision
61d
Days
Class 2
Risk

K032134 is an FDA 510(k) clearance for the TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Kronus Market Development Associates, Inc. (Boise, US). The FDA issued a Cleared decision on September 10, 2003 after a review of 61 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 Kronus Market Development Associates, Inc. devices

FDA 510(k) Submission Details - K032134

510(k) Number K032134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2003
Decision Date September 10, 2003
Days to Decision 61 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 105d · This submission: 61d
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 73
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K032134.
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
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