Cleared Traditional

K983553 - ANTI-TG IGG ELISA TEST SYSTEM

K983553 is an FDA 510(k) clearance for ANTI-TG 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 59-day FDA review.

K983553 · Columbia Bioscience, Inc. · Immunology device
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Dec 1998
Decision
59d
Days
Class 2
Risk

K983553 is an FDA 510(k) clearance for the ANTI-TG 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 December 7, 1998 after a review of 59 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 - K983553

510(k) Number K983553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1998
Decision Date December 07, 1998
Days to Decision 59 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
46d faster than avg
Panel avg: 105d · This submission: 59d
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 K983553.
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT
K984165 · The Binding Site, Ltd. · Feb 1999
IS ANTI-TPO IGG ELISA TEST SYSTEM
K984228 · Columbia Bioscience, Inc. · Feb 1999
NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY
K983992 · Nichols Institute Diagnostics · Jan 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521
K982866 · Nichols Institute Diagnostics · Oct 1998
AIA-PACK TPOAB ASSAY
K981521 · Tosoh Medics, Inc. · Oct 1998
AIA-PACK TGAB ASSAY
K981522 · Tosoh Medics, Inc. · Oct 1998