Cleared Traditional

K952130 - ORGENTEC ANTI-TG ELISA

K952130 is the FDA 510(k) clearance for ORGENTEC ANTI-TG ELISA 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 43-day FDA review.

K952130 · American Laboratory Products Co., Ltd. · Immunology device
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Jun 1995
Decision
43d
Days
Class 2
Risk

K952130 is an FDA 510(k) clearance for the ORGENTEC ANTI-TG ELISA. 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 June 20, 1995 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Laboratory Products Co., Ltd. devices

Submission Details

510(k) Number K952130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date June 20, 1995
Days to Decision 43 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
61d faster than avg
Panel avg: 104d · This submission: 43d
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 51
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K952130.
DIASTAT ANTI-THYROID PEROXIDASE KIT
K951487 · Shield Diagnostics, Ltd. · Jun 1995
DIASTAT ANTI-THYROGLOBULIN KIT
K952183 · Shield Diagnostics, Ltd. · Jun 1995
ORGENTEC ANTI-TPO ELISA
K952129 · American Laboratory Products Co., Ltd. · Jun 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