Cleared Traditional

K911175 - SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG S...

K911175 is the FDA 510(k) clearance for SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG S... by Serono-Baker Diagnostics, Inc.. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K911175 · Serono-Baker Diagnostics, Inc. · Immunology device
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Apr 1991
Decision
18d
Days
Class 2
Risk

K911175 is an FDA 510(k) clearance for the SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE). Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Serono-Baker Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on April 5, 1991 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - 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: 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-Baker Diagnostics, Inc. devices

Submission Details

510(k) Number K911175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1991
Decision Date April 05, 1991
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 104d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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.

Regulatory Peers - DBF Ferritin, Antigen, Antiserum, Control

All 64
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