Cleared Traditional

K080159 - KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT

K080159 is an FDA 510(k) clearance for KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB)..., 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 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

FDA 510(k) Submission Details - K080159

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
15d slower than avg
Panel avg: 105d · This submission: 120d
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 K080159.
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
K090760 · Theratest Laboratories, Inc. · Sep 2009
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
K083391 · Diagnostic Hybrids, Inc. · May 2009
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092 · Roche Diagnostics Corp. · Jul 2008
FIDIS TM THYRO, MODEL MX002
K061794 · Biomedical Diagnostics (Bmd) SA · Nov 2006
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
K052407 · Fisher Diagnostics · Jul 2006
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
K061382 · Beckman Coulter, Inc. · Jul 2006