Cleared Traditional

IMMULITE 2000 THYROGLOBULIN MODEL L2KTY (K982468) - FDA 510(k) Clearance

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

K982468 · Diagnostic Products Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Mar 1999
Decision
240d
Days
Class 2
Risk

K982468 is an FDA 510(k) clearance for the IMMULITE 2000 THYROGLOBULIN MODEL L2KTY. Classified as System, Test, Thyroglobulin (product code MSW), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 12, 1999 after a review of 240 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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 K982468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1998
Decision Date March 12, 1999
Days to Decision 240 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
136d slower than avg
Panel avg: 104d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSW System, Test, Thyroglobulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 - MSW System, Test, Thyroglobulin

All 12
Devices cleared under the same product code (MSW) and FDA review panel - the closest regulatory comparables to K982468.
Atellica IM Thyroglobulin (Tg)
K242981 · Siemens Healthcare Diagnostics, Inc. · Jun 2025
Access Thyroglobulin
K240927 · Beckman Coulter, Inc. · Jun 2024
Access Thyroglobulin
K241423 · Beckman Coulter, Inc. · Jun 2024
Elecsys Tg II
K221890 · Roche Diagnostics · Sep 2023
Access Thyroglobulin
K220972 · Beckman Coulter, Inc. · Sep 2023
IMMULITE THYROGLOBULIN MODEL LKTY
K982466 · Diagnostic Products Corp. · Mar 1999