Cleared Traditional

FITC MURINE MONOCLONAL ANTI-RSV IGG (K884516) - FDA 510(k) Clearance

Class I Microbiology device.

K884516 · Whittaker Bioproducts, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1989
Decision
78d
Days
Class 1
Risk

K884516 is an FDA 510(k) clearance for the FITC MURINE MONOCLONAL ANTI-RSV IGG. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on January 13, 1989 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3480 - 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 Whittaker Bioproducts, Inc. devices

Submission Details

510(k) Number K884516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1988
Decision Date January 13, 1989
Days to Decision 78 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 102d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3480
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 - GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

All 31
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K884516.
Clungene RSV Antigen Rapid Test
K253318 · Hangzhou Clongene Biotech Co., Ltd. · Jan 2026
Nano-Check™ RSV Test
K240280 · Nano-Ditech Corporation · Jul 2024
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
K133140 · Becton, Dickinson & CO · Nov 2013
BD DIRECTIGEN EZ RSV
K101514 · Becton, Dickinson & CO · Jul 2010
SAS RSV TEST
K022845 · Sa Scientific, Inc. · Jan 2003
BD DIRECTIGEN EZ RSV KIT
K022133 · Becton, Dickinson & CO · Dec 2002