Cleared Traditional

K130398 - SOFIA RSV FIA

K130398 is the FDA 510(k) clearance for SOFIA RSV FIA by Quidel Corp.. It is a Class 1 Microbiology device (product code GQG) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K130398 · Quidel Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
175d
Days
Class 1
Risk

K130398 is an FDA 510(k) clearance for the SOFIA(R) RSV FIA. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on August 13, 2013 after a review of 175 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 Quidel Corp. devices

Submission Details

510(k) Number K130398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2013
Decision Date August 13, 2013
Days to Decision 175 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
73d slower than avg
Panel avg: 102d · This submission: 175d
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.

Clinical Evidence

ClinicalTrials.gov
NCT01734668 Completed Observational Industry-sponsored

Sofia RSV FIA Field Study

2468
Patients (actual)
17
Sites
Condition studied Respiratory Syncytial Virus
Eligibility All sexes
Principal investigator John D Tamerius, PhD
Sponsor Quidel Corporation (industry)
Started 2012-03-01 → Primary completion 2013-01-01
Primary outcome
High level of sensitivity and specificity for performance vs. culture
Study completed - no results published. This trial concluded in 2013 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

All 15
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K130398.
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 VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
K132456 · Becton, Dickinson and Company · Nov 2013
BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
K121633 · Becton, Dickinson and Company · Sep 2012
QUICKVUE RSV 10
K101918 · Quidel Corp. · Sep 2010
BD DIRECTIGEN EZ RSV
K101514 · Becton, Dickinson & CO · Jul 2010