Cleared Traditional

K982866 - NICHOLS ADVANTAGE CHEMILUMINESCENCE THY...

K982866 is the FDA 510(k) clearance for NICHOLS ADVANTAGE CHEMILUMINESCENCE THY... by Nichols Institute Diagnostics. It is a Class 2 Immunology device (product code JZO) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K982866 · Nichols Institute Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
63d
Days
Class 2
Risk

K982866 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOA.... Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on October 16, 1998 after a review of 63 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 Diagnostics devices

Submission Details

510(k) Number K982866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1998
Decision Date October 16, 1998
Days to Decision 63 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 104d · This submission: 63d
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 40
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K982866.
ANTI-TPO EIA DIAGNOSTIC TEST KIT
K984163 · The Binding Site, Ltd. · Feb 1999
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT
K984165 · The Binding Site, Ltd. · Feb 1999
NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY
K983992 · Nichols Institute Diagnostics · Jan 1999
AIA-PACK TPOAB ASSAY
K981521 · Tosoh Medics, Inc. · Oct 1998
AIA-PACK TGAB ASSAY
K981522 · Tosoh Medics, Inc. · Oct 1998
IMMULITE ANTI-TG AB
K980206 · Diagnostic Products Corp. · May 1998