Cleared Traditional

K823348 - H. INFLUENZA B ANTISERA FOR CIE

K823348 is an FDA 510(k) clearance for H. INFLUENZA B ANTISERA FOR CIE, manufactured by Diagnostica, Inc.. The device is a Class 2 Immunology device with product code GRP cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K823348 · Diagnostica, Inc. · Immunology device
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Dec 1982
Decision
49d
Days
Class 2
Risk

K823348 is an FDA 510(k) clearance for the H. INFLUENZA B ANTISERA FOR CIE. Classified as Antisera, All Types, H. Influenza (product code GRP), Class II - Special Controls.

Submitted by Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3300 - 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 Diagnostica, Inc. devices

FDA 510(k) Submission Details - K823348

510(k) Number K823348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1982
Decision Date December 28, 1982
Days to Decision 49 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 105d · This submission: 49d
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 Immunology 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 K823348.
BACTIGEN(R) H. INFLUENZAE TYPE B
K884967 · Armkel, LLC · Feb 1989
IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
K854490 · American Micro Scan · Dec 1985
H-FLU B ELISA TEST
K831525 · Seragen Diagnostics, Inc. · Sep 1983
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