Cleared Traditional

K982466 - IMMULITE THYROGLOBULIN MODEL LKTY

K982466 is the FDA 510(k) clearance for IMMULITE THYROGLOBULIN MODEL LKTY by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code MSW) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K982466 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
240d
Days
Class 2
Risk

K982466 is an FDA 510(k) clearance for the IMMULITE THYROGLOBULIN MODEL LKTY. 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 K982466 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 10
Devices cleared under the same product code (MSW) and FDA review panel - the closest regulatory comparables to K982466.
NICHOLS ADVANTAGE THYROGLOB
K002888 · Nichols Institute Diagnostics · Oct 2000
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
K002905 · Beckman Coulter, Inc. · Oct 2000
NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
K994140 · Nichols Institute Diagnostics · May 2000
IMMULITE 2000 THYROGLOBULIN MODEL L2KTY
K982468 · Diagnostic Products Corp. · Mar 1999