Cleared Traditional

K854490 - IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES

K854490 is an FDA 510(k) clearance for IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE..., manufactured by American Micro Scan. The device is a Class 2 Microbiology device with product code GRP cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K854490 · American Micro Scan · Microbiology device
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Dec 1985
Decision
45d
Days
Class 2
Risk

K854490 is an FDA 510(k) clearance for the IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES. Classified as Antisera, All Types, H. Influenza (product code GRP), Class II - Special Controls.

Submitted by American Micro Scan (Sacramento, US). The FDA issued a Cleared decision on December 27, 1985 after a review of 45 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 American Micro Scan devices

FDA 510(k) Submission Details - K854490

510(k) Number K854490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date December 27, 1985
Days to Decision 45 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
57d faster than avg
Panel avg: 102d · This submission: 45d
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 K854490.
BACTIGEN(R) H. INFLUENZAE TYPE B
K884967 · Armkel, LLC · Feb 1989
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