Cleared Traditional

K924186 - LPIA-FERRITIN ASSAY

K924186 is an FDA 510(k) clearance for LPIA-FERRITIN ASSAY, manufactured by Seradyn, Inc.. The device is a Class 1 Immunology device with product code DEF cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K924186 · Seradyn, Inc. · Immunology device
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Dec 1992
Decision
125d
Days
Class 1
Risk

K924186 is an FDA 510(k) clearance for the LPIA-FERRITIN ASSAY. Classified as Alpha-2-hs-glycoprotein, Antigen, Antiserum, Control (product code DEF), Class I - General Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 23, 1992 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5425 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Seradyn, Inc. devices

FDA 510(k) Submission Details - K924186

510(k) Number K924186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1992
Decision Date December 23, 1992
Days to Decision 125 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 105d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

DEF Device Classification - Class 1, General Controls

Product Code DEF Alpha-2-hs-glycoprotein, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5425
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.