Cleared Traditional

K874127 - ABBOTT TESTPACK RSV

K874127 is an FDA 510(k) clearance for ABBOTT TESTPACK RSV, manufactured by Abbott Laboratories. The device is a Class 1 Microbiology device with product code GQG cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K874127 · Abbott Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
206d
Days
Class 1
Risk

K874127 is an FDA 510(k) clearance for the ABBOTT TESTPACK RSV. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 6, 1988 after a review of 206 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K874127

510(k) Number K874127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date May 06, 1988
Days to Decision 206 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
104d slower than avg
Panel avg: 102d · This submission: 206d
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 K874127.
FITC MURINE MONOCLONAL ANTI-RSV IGG
K884516 · Whittaker Bioproducts, Inc. · Jan 1989
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
K882629 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
K882277 · Abbott Laboratories · Jun 1988
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
K862743 · Kallestad Laboratories, Inc. · Sep 1986
ABBOTT RSV EIA
K862429 · Abbott Laboratories · Sep 1986
RESPIRATORY SYNCYTIAL VIRUS ID REAGENT
K853695 · Viromed Laboratories, Inc. · Dec 1985