Cleared Traditional

K931311 - THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT

K931311 is an FDA 510(k) clearance for THYROID PEROXIDASE AUTO ANTIBODIES(TPO)..., manufactured by Nichols Institute. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K931311 · Nichols Institute · Immunology device
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May 1993
Decision
60d
Days
Class 2
Risk

K931311 is an FDA 510(k) clearance for the THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Nichols Institute (San Juan Capistrano, US). The FDA issued a Cleared decision on May 14, 1993 after a review of 60 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 Nichols Institute devices

FDA 510(k) Submission Details - K931311

510(k) Number K931311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1993
Decision Date May 14, 1993
Days to Decision 60 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
45d faster than avg
Panel avg: 105d · This submission: 60d
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 72
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K931311.
ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)
K950088 · 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
AUTOSTAT ANTITHYROGLOBIN
K925784 · Cogent Diagnotics , Ltd. · Jan 1993
AUTOSTAT ANTI-THYROID MICROSOMAL KIT
K925785 · Cogent Diagnotics , Ltd. · Jan 1993