Cleared Traditional

K040925 - NORMAL AND HYPERGAMMA CONTROL SERUM

K040925 is the FDA 510(k) clearance for NORMAL AND HYPERGAMMA CONTROL SERUM by Sebia. It is a Class 1 Immunology device (product code JJY) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K040925 · Sebia · Immunology device
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Apr 2004
Decision
20d
Days
Class 1
Risk

K040925 is an FDA 510(k) clearance for the NORMAL AND HYPERGAMMA CONTROL SERUM. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Sebia (Chelsea, US). The FDA issued a Cleared decision on April 28, 2004 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - 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 Sebia devices

Submission Details

510(k) Number K040925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2004
Decision Date April 28, 2004
Days to Decision 20 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 104d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 464
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K040925.
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