Cleared Traditional

K090760 - THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120

K090760 is an FDA 510(k) clearance for THERATEST EL-ANTI-TPO AND THERATEST EL-..., manufactured by Theratest Laboratories, Inc.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K090760 · Theratest Laboratories, Inc. · Immunology device
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Sep 2009
Decision
164d
Days
Class 2
Risk

K090760 is an FDA 510(k) clearance for the THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103.... Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on September 3, 2009 after a review of 164 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 Theratest Laboratories, Inc. devices

FDA 510(k) Submission Details - K090760

510(k) Number K090760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2009
Decision Date September 03, 2009
Days to Decision 164 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 105d · This submission: 164d
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 K090760.
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
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K092229 · Diagnostic Hybrids, Inc. · May 2010
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
K083391 · Diagnostic Hybrids, Inc. · May 2009
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
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ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
K052407 · Fisher Diagnostics · Jul 2006