Cleared Traditional

K982468 - IMMULITE 2000 THYROGLOBULIN MODEL L2KTY

K982468 is an FDA 510(k) clearance for IMMULITE 2000 THYROGLOBULIN MODEL L2KTY, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code MSW cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K982468 · Diagnostic Products Corp. · Immunology device
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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

FDA 510(k) Submission Details - K982468

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
135d slower than avg
Panel avg: 105d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSW Device Classification - Class 2, Special Controls

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.