Cleared Traditional

K092229 - THYRETAIN TM TSI REPORTER BIOASSAY

K092229 is an FDA 510(k) clearance for THYRETAIN TM TSI REPORTER BIOASSAY, manufactured by Diagnostic Hybrids, Inc.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K092229 · Diagnostic Hybrids, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
299d
Days
Class 2
Risk

K092229 is an FDA 510(k) clearance for the THYRETAIN TM TSI REPORTER BIOASSAY. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on May 18, 2010 after a review of 299 days - an extended review 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: 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 Diagnostic Hybrids, Inc. devices

FDA 510(k) Submission Details - K092229

510(k) Number K092229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2009
Decision Date May 18, 2010
Days to Decision 299 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 105d · This submission: 299d
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 71
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K092229.
Elecsys Anti-TSHR
K193313 · Roche Diagnostics · Feb 2020
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
K151799 · Phadia AB · Mar 2016
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
K152061 · Siemens Healthcare Diagnostics, Inc. · Mar 2016
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