Cleared Traditional

K902609 - DIRECTIGEN FLU A

K902609 is an FDA 510(k) clearance for DIRECTIGEN FLU A, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Microbiology device with product code GNT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K902609 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Sep 1990
Decision
90d
Days
Class 1
Risk

K902609 is an FDA 510(k) clearance for the DIRECTIGEN FLU A. Classified as Antigens, Ha (including Ha Control), Influenza Virus A, B, C (product code GNT), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 10, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3330 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K902609

510(k) Number K902609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1990
Decision Date September 10, 1990
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

GNT Device Classification - Class 1, General Controls

Product Code GNT Antigens, Ha (including Ha Control), Influenza Virus A, B, C
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3330
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GNT Antigens, Ha (including Ha Control), Influenza Virus A, B, C

Devices cleared under the same product code (GNT) and FDA review panel - the closest regulatory comparables to K902609.
VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
K950838 · Zymetx, Inc. · Jun 1996
QTEST INFLUENZA A
K913828 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1991
INFLUENZA HA ANTIGEN
K780272 · Flow Laboratories, Inc. · Feb 1978
INFLUENZA HA ANTIGEN A/USSR
K780275 · Flow Laboratories, Inc. · Feb 1978