Cleared Traditional

H-FLU B ELISA TEST (K831525) - FDA 510(k) Clearance

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

K831525 · Seragen Diagnostics, Inc. · Microbiology device
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Sep 1983
Decision
140d
Days
Class 2
Risk

K831525 is an FDA 510(k) clearance for the H-FLU B ELISA TEST. Classified as Antisera, All Types, H. Influenza (product code GRP), Class II - Special Controls.

Submitted by Seragen Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3300 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Seragen Diagnostics, Inc. devices

Submission Details

510(k) Number K831525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1983
Decision Date September 29, 1983
Days to Decision 140 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 102d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GRP Antisera, All Types, H. Influenza
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3300
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 Microbiology devices follow this clearance model.