Cleared Traditional

K950090 - ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)

K950090 is the FDA 510(k) clearance for ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY) by American Laboratory Products Co., Ltd.. It is a Class 2 Immunology device (product code JZO) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K950090 · American Laboratory Products Co., Ltd. · Immunology device
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Apr 1995
Decision
101d
Days
Class 2
Risk

K950090 is an FDA 510(k) clearance for the ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY). Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by American Laboratory Products Co., Ltd. (Windham, US). The FDA issued a Cleared decision on April 21, 1995 after a review of 101 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 American Laboratory Products Co., Ltd. devices

Submission Details

510(k) Number K950090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1995
Decision Date April 21, 1995
Days to Decision 101 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
3d faster than avg
Panel avg: 104d · This submission: 101d
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 54
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K950090.
ORGENTEC ANTI-TG ELISA
K952130 · American Laboratory Products Co., Ltd. · Jun 1995
ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)
K950217 · American Laboratory Products Co., Ltd. · Apr 1995
ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)
K950088 · American Laboratory Products Co., Ltd. · Apr 1995
QUANTA LITE(TM) THYROID M ELISA
K930485 · Inova Diagnostics, Inc. · Mar 1993
AUTOSTAT ANTITHYROGLOBIN
K925784 · Cogent Diagnotics , Ltd. · Jan 1993
AUTOSTAT ANTI-THYROID MICROSOMAL KIT
K925785 · Cogent Diagnotics , Ltd. · Jan 1993