Cleared Traditional

K902748 - SEROZYME FREE T3 IMMUNOASSAY

K902748 is an FDA 510(k) clearance for SEROZYME FREE T3 IMMUNOASSAY, manufactured by Advanced Magnetics, Inc.. The device is a Class 2 Toxicology device with product code KHQ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K902748 · Advanced Magnetics, Inc. · Toxicology device
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Aug 1990
Decision
48d
Days
Class 2
Risk

K902748 is an FDA 510(k) clearance for the SEROZYME FREE T3 IMMUNOASSAY. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Advanced Magnetics, Inc. (Cambridge, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1715 - the FDA toxicology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Magnetics, Inc. devices

FDA 510(k) Submission Details - K902748

510(k) Number K902748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1990
Decision Date August 09, 1990
Days to Decision 48 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 87d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHQ Device Classification - Class 2, Special Controls

Product Code KHQ Radioassay, Triiodothyronine Uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1715
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 Toxicology devices follow this clearance model.

Regulatory Peers - KHQ Radioassay, Triiodothyronine Uptake

All 74
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K902748.
SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)
K911912 · Serono-Baker Diagnostics, Inc. · Sep 1991
CIBA CORNING ACS T UPTAKE IMMUNOASSAY
K911093 · Ciba Corning Diagnostics Corp. · Apr 1991
IL T UPTAKE ASSAY SYSTEM
K903396 · Instrumentation Laboratory CO · Oct 1990
OPUS TM T-UPTAKE TEST SYSTEM
K902797 · Pb Diagnostic Systems, Inc. · Jul 1990
FIAGEN T3 UPTAKE CATALOGUE #101-402
K895186 · Cyberfluor, Inc. · Nov 1989
EMIT T-UPTAKE ASSAY
K894145 · Syva Co. · Sep 1989