Cleared Traditional

IMMULITE ANTI-TG AB (K980206) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980206 · Diagnostic Products Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
May 1998
Decision
101d
Days
Class 2
Risk

K980206 is an FDA 510(k) clearance for the IMMULITE ANTI-TG AB. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on May 1, 1998 after a review of 101 days - within the typical 510(k) review window.

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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K980206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1998
Decision Date May 01, 1998
Days to Decision 101 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
3d faster than avg
Panel avg: 104d · This submission: 101d
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 91
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K980206.
ADVIA Centaur Anti-Thyroid Peroxidase II
K250250 · Siemens Healthcare Diagnostics, Inc. · Oct 2025
Access TPO Antibody
K240469 · Beckman Coulter, Inc. · Aug 2024
Access Thyroglobulin Antibody II
K213517 · Beckman Coulter, Inc. · Sep 2023
Elecsys Anti-Tg
K222610 · Roche Diagnostics · Sep 2023
Elecsys Anti-TSHR
K193313 · Roche Diagnostics · Feb 2020
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
K991094 · Diagnostic Products Corp. · May 1999