Cleared Traditional

K831525 - H-FLU B ELISA TEST

K831525 is an FDA 510(k) clearance for H-FLU B ELISA TEST, manufactured by Seragen Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code GRP cleared through the Traditional 510(k) pathway after a 140-day FDA review.

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

FDA 510(k) Submission Details - K831525

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
Combination Product No
PCCP Authorized No
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.

GRP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GRP Antisera, All Types, H. Influenza

Devices cleared under the same product code (GRP) and FDA review panel - the closest regulatory comparables to K831525.
BACTIGEN(R) H. INFLUENZAE TYPE B
K884967 · Armkel, LLC · Feb 1989
IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
K854490 · American Micro Scan · Dec 1985
BBL DIRECTIGEN MENINGITIS TEST KIT
K821266 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1982
HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM
K820192 · Hyland Therapeutic Div., Travenol Laboratories · Mar 1982