Cleared Traditional

K882629 - DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT

K882629 is an FDA 510(k) clearance for DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS ..., manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Microbiology device with product code GQG cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K882629 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Oct 1988
Decision
126d
Days
Class 1
Risk

K882629 is an FDA 510(k) clearance for the DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 31, 1988 after a review of 126 days - within the typical 510(k) review window.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K882629

510(k) Number K882629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1988
Decision Date October 31, 1988
Days to Decision 126 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
24d slower than avg
Panel avg: 102d · This submission: 126d
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 28
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K882629.
RSV ANTIGEN CONTROL SLIDES
K964870 · Viral Antigens, Inc. · Mar 1997
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
K896097 · Vitek Systems, Inc. · Feb 1990
FITC MURINE MONOCLONAL ANTI-RSV IGG
K884516 · Whittaker Bioproducts, Inc. · Jan 1989
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
K882277 · Abbott Laboratories · Jun 1988
ABBOTT TESTPACK RSV
K874127 · Abbott Laboratories · May 1988
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
K862743 · Kallestad Laboratories, Inc. · Sep 1986