Cleared Traditional

K080159 - KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB)...

K080159 is the FDA 510(k) clearance for KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB)... by Kronus Market Development Associates, Inc.. It is a Class 2 Immunology device (product code JZO) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K080159 · Kronus Market Development Associates, Inc. · Immunology device
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May 2008
Decision
120d
Days
Class 2
Risk

K080159 is an FDA 510(k) clearance for the KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA 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 May 22, 2008 after a review of 120 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 Kronus Market Development Associates, Inc. devices

Submission Details

510(k) Number K080159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2008
Decision Date May 22, 2008
Days to Decision 120 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
16d slower than avg
Panel avg: 104d · This submission: 120d
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 K080159.
THYRETAIN TM TSI REPORTER BIOASSAY
K092229 · Diagnostic Hybrids, Inc. · May 2010
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
K083391 · Diagnostic Hybrids, Inc. · May 2009
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092 · Roche Diagnostics Corp. · Jul 2008
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
K061382 · Beckman Coulter, Inc. · Jul 2006
ROCHE ELECSYS ANTI-TG
K053426 · Roche Diagnostics Corp. · Feb 2006
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
K051890 · Roche Diagnostics Corp. · Aug 2005