Cleared Traditional

K911217 - SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOL...

K911217 is the FDA 510(k) clearance for SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOL... by Serono-Baker Diagnostics, Inc.. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K911217 · Serono-Baker Diagnostics, Inc. · Chemistry device
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Aug 1991
Decision
150d
Days
Class 2
Risk

K911217 is an FDA 510(k) clearance for the SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE). Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Serono-Baker Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on August 16, 1991 after a review of 150 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 K911217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1991
Decision Date August 16, 1991
Days to Decision 150 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 88d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 58
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