Cleared Traditional

K981521 - AIA-PACK TPOAB ASSAY

K981521 is an FDA 510(k) clearance for AIA-PACK TPOAB ASSAY, manufactured by Tosoh Medics, Inc.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K981521 · Tosoh Medics, Inc. · Immunology device
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Oct 1998
Decision
163d
Days
Class 2
Risk

K981521 is an FDA 510(k) clearance for the AIA-PACK TPOAB ASSAY. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (Foster City, US). The FDA issued a Cleared decision on October 8, 1998 after a review of 163 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tosoh Medics, Inc. devices

FDA 510(k) Submission Details - K981521

510(k) Number K981521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1998
Decision Date October 08, 1998
Days to Decision 163 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
58d slower than avg
Panel avg: 105d · This submission: 163d
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 71
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K981521.
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
AIA-PACK TGAB ASSAY
K981522 · Tosoh Medics, Inc. · Oct 1998
UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY
K981559 · Pharmacia & Upjohn Co. · Jul 1998
UNICAP THYROID PEROXIDASE IGG
K981930 · Pharmacia & Upjohn Co. · Jul 1998