Cleared Traditional

K022133 - BD DIRECTIGEN EZ RSV KIT

K022133 is an FDA 510(k) clearance for BD DIRECTIGEN EZ RSV KIT, manufactured by Becton, Dickinson & CO. The device is a Class 1 Microbiology device with product code GQG cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K022133 · Becton, Dickinson & CO · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
162d
Days
Class 1
Risk

K022133 is an FDA 510(k) clearance for the BD DIRECTIGEN EZ RSV KIT. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on December 10, 2002 after a review of 162 days - an extended review 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: 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 Becton, Dickinson & CO devices

FDA 510(k) Submission Details - K022133

510(k) Number K022133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2002
Decision Date December 10, 2002
Days to Decision 162 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 102d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

GQG Device Classification - Class 1, General Controls

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 25
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K022133.
IMMUNOCARD STAT! RSV MODEL #750630
K041445 · Meridian Bioscience, Inc. · Aug 2004
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
K032166 · Binax, Inc. · Oct 2003
SAS RSV TEST
K022845 · Sa Scientific, Inc. · Jan 2003
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK
K021687 · Binax, Inc. · Sep 2002
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
K896097 · Vitek Systems, Inc. · Feb 1990
FITC MURINE MONOCLONAL ANTI-RSV IGG
K884516 · Whittaker Bioproducts, Inc. · Jan 1989