Cleared Traditional

K984228 - IS ANTI-TPO IGG ELISA TEST SYSTEM

K984228 is an FDA 510(k) clearance for IS ANTI-TPO IGG ELISA TEST SYSTEM, manufactured by Columbia Bioscience, Inc.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K984228 · Columbia Bioscience, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
69d
Days
Class 2
Risk

K984228 is an FDA 510(k) clearance for the IS ANTI-TPO IGG ELISA TEST SYSTEM. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Columbia Bioscience, Inc. (Columbia, US). The FDA issued a Cleared decision on February 2, 1999 after a review of 69 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 Columbia Bioscience, Inc. devices

FDA 510(k) Submission Details - K984228

510(k) Number K984228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1998
Decision Date February 02, 1999
Days to Decision 69 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
36d faster than avg
Panel avg: 105d · This submission: 69d
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 69
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K984228.
IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
K991096 · Diagnostic Products Corp. · May 1999
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
ANTI-TG IGG ELISA TEST SYSTEM
K983553 · Columbia Bioscience, Inc. · Dec 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521
K982866 · Nichols Institute Diagnostics · Oct 1998