Cleared Traditional

K883085 - T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG...

K883085 is the FDA 510(k) clearance for T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG... by Serono Diagnostics, Inc.. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K883085 · Serono Diagnostics, Inc. · Chemistry device
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Sep 1988
Decision
49d
Days
Class 2
Risk

K883085 is an FDA 510(k) clearance for the T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on September 9, 1988 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1715 - the FDA in vitro diagnostics and chemistry 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 Serono Diagnostics, Inc. devices

Submission Details

510(k) Number K883085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1988
Decision Date September 09, 1988
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.

Regulatory Peers - KHQ Radioassay, Triiodothyronine Uptake

All 55
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K883085.
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