Cleared Traditional

SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) (K911912) - FDA 510(k) Clearance

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

K911912 · Serono-Baker Diagnostics, Inc. · Chemistry device
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Sep 1991
Decision
141d
Days
Class 2
Risk

K911912 is an FDA 510(k) clearance for the SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE). Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Serono-Baker Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on September 18, 1991 after a review of 141 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Serono-Baker Diagnostics, Inc. devices

Submission Details

510(k) Number K911912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1991
Decision Date September 18, 1991
Days to Decision 141 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 88d · This submission: 141d
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 92
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K911912.
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K934312 · Abbott Laboratories · Jun 1994
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS
K926443 · Roche Diagnostic Systems, Inc. · May 1993
VISTA THYROXINE UPTAKE ASSAY
K923676 · Syva Co. · Oct 1992
IL T UPTAKE ASSAY SYSTEM
K903396 · Instrumentation Laboratory CO · Oct 1990