Cleared Traditional

K950088 - ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)

K950088 is an FDA 510(k) clearance for ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMU..., manufactured by American Laboratory Products Co., Ltd.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K950088 · American Laboratory Products Co., Ltd. · Immunology device
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Apr 1995
Decision
101d
Days
Class 2
Risk

K950088 is an FDA 510(k) clearance for the ORGENTEC ANTI-TG/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

FDA 510(k) Submission Details - K950088

510(k) Number K950088 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
4d faster than avg
Panel avg: 105d · This submission: 101d
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 K950088.
ORGENTEC ANTI-TPO ELISA
K952129 · American Laboratory Products Co., Ltd. · Jun 1995
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 PIA (PIN IMMUNO ASSAY)
K950089 · American Laboratory Products Co., Ltd. · Apr 1995
ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)
K950090 · American Laboratory Products Co., Ltd. · Apr 1995
QUANTA LITE(TM) THYROID M ELISA
K930485 · Inova Diagnostics, Inc. · Mar 1993