Cleared Traditional

K884967 - BACTIGEN(R) H. INFLUENZAE TYPE B

K884967 is an FDA 510(k) clearance for BACTIGEN H. INFLUENZAE TYPE B, manufactured by Armkel, LLC. The device is a Class 2 Microbiology device with product code GRP cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K884967 · Armkel, LLC · Microbiology device
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Feb 1989
Decision
69d
Days
Class 2
Risk

K884967 is an FDA 510(k) clearance for the BACTIGEN(R) H. INFLUENZAE TYPE B. Classified as Antisera, All Types, H. Influenza (product code GRP), Class II - Special Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on February 7, 1989 after a review of 69 days - a notably fast clearance cycle.

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: 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 Armkel, LLC devices

FDA 510(k) Submission Details - K884967

510(k) Number K884967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1988
Decision Date February 07, 1989
Days to Decision 69 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
33d faster than avg
Panel avg: 102d · This submission: 69d
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 K884967.
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