Cleared Traditional

K022845 - SAS RSV TEST

K022845 is the FDA 510(k) clearance for SAS RSV TEST by Sa Scientific, Inc.. It is a Class 1 Microbiology device (product code GQG) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K022845 · Sa Scientific, Inc. · Microbiology device
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Jan 2003
Decision
155d
Days
Class 1
Risk

K022845 is an FDA 510(k) clearance for the SAS RSV TEST. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on January 29, 2003 after a review of 155 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 Sa Scientific, Inc. devices

Submission Details

510(k) Number K022845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2002
Decision Date January 29, 2003
Days to Decision 155 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 102d · This submission: 155d
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 17
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K022845.
QUICKVUE RSV 10
K101918 · Quidel Corp. · Sep 2010
BD DIRECTIGEN EZ RSV
K101514 · Becton, Dickinson & CO · Jul 2010
QUICK VUE RSV TEST, MODELS 20193, 20199
K070747 · Quidel Corp. · Apr 2007
BD DIRECTIGEN EZ RSV KIT
K022133 · Becton, Dickinson & CO · Dec 2002
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