Cleared Traditional

K884191 - INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION

K884191 is an FDA 510(k) clearance for INFLUENZA A IFA TEST FOR DIRECT ANTIGEN..., manufactured by Baxter Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code GNX cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K884191 · Baxter Diagnostics, Inc. · Microbiology device
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Nov 1988
Decision
47d
Days
Class 1
Risk

K884191 is an FDA 510(k) clearance for the INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION. Classified as Antigens, Cf (including Cf Control), Influenza Virus A, B, C (product code GNX), Class I - General Controls.

Submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on November 22, 1988 after a review of 47 days - a notably fast clearance cycle.

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: 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 Baxter Diagnostics, Inc. devices

FDA 510(k) Submission Details - K884191

510(k) Number K884191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date November 22, 1988
Days to Decision 47 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
55d faster than avg
Panel avg: 102d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

GNX Device Classification - Class 1, General Controls

Product Code GNX Antigens, Cf (including Cf 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 - GNX Antigens, Cf (including Cf Control), Influenza Virus A, B, C

All 13
Devices cleared under the same product code (GNX) and FDA review panel - the closest regulatory comparables to K884191.
BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY
K924006 · Baxter Healthcare Corp · Dec 1992
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B
K901493 · Whittaker Bioproducts, Inc. · Jun 1990
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A
K893579 · Whittaker Bioproducts, Inc. · Jan 1990
IMAGEN INFLUENZA VIRUS A AND B TESTMI
K872958 · Boots-Celltech Diagnostics, Inc. · Feb 1988
INFLUENZA A & B S-ANTIGEN & CONTROLS
K802931 · Orion Diagnostica, Inc. · Jan 1981