Cleared Traditional

K893579 - FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A

K893579 is an FDA 510(k) clearance for FITC MURINE MONOCLONAL ANTI-INFLUENZA T..., manufactured by Whittaker Bioproducts, Inc.. The device is a Class 1 Microbiology device with product code GNX cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K893579 · Whittaker Bioproducts, Inc. · Microbiology device
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Jan 1990
Decision
252d
Days
Class 1
Risk

K893579 is an FDA 510(k) clearance for the FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A. Classified as Antigens, Cf (including Cf Control), Influenza Virus A, B, C (product code GNX), Class I - General Controls.

Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on January 16, 1990 after a review of 252 days - an extended review 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: 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 Whittaker Bioproducts, Inc. devices

FDA 510(k) Submission Details - K893579

510(k) Number K893579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1989
Decision Date January 16, 1990
Days to Decision 252 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
150d slower than avg
Panel avg: 102d · This submission: 252d
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 K893579.
VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
K971494 · Zymetx, Inc. · Sep 1997
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
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION
K884191 · Baxter Diagnostics, Inc. · Nov 1988
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