Cleared Traditional

K161375 - Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161375 · Alere Scarborough, Inc. · Microbiology device
Aug 2016
Decision
92d
Days
Class 2
Risk

K161375 is an FDA 510(k) clearance for the Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit. Classified as Respiratory Virus Panel Nucleic Acid Assay System (product code OCC), Class II - Special Controls.

Submitted by Alere Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on August 18, 2016 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - 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.

Submission Details

510(k) Number K161375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2016
Decision Date August 18, 2016
Days to Decision 92 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 174d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCC Respiratory Virus Panel Nucleic Acid Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition A Respiratory Viral Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Viral Nucleic Acids Extracted From Human Respiratory Specimens Or Viral Culture. The Detection And Identification Of A Specific Viral Nucleic Acid From Individuals Exhibiting Signs And Symptoms Of Respiratory Infection Aids In The Diagnosis Of Respiratory Viral Infection When Used In Conjunction With Other Clinical And Laboratory Findings. The Device Is Intended For Detection And Identification Of A Combination Of The Following Viruses: Influenza A And Influenza B, Influenza A Subtype H1 And Influenza A Subtype H3, Respiratory Syncytial Virus Subtype A And Respiratory Syncytial Virus Subtype B, Parainfluenza 1, Parainfluenza 2, And Parainfluenza 3 Virus, Human Metapneumovirus, Rhinovirus, And Adenovirus.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - OCC Respiratory Virus Panel Nucleic Acid Assay System

Devices cleared under the same product code (OCC) and FDA review panel - the closest regulatory comparables to K161375.
NxTAG® Respiratory Pathogen Panel
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Panther Fusion AdV/hMPV/RV Assay
K231017 · Hologic, Inc. · May 2023
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K213822 · Roche Molecular Systems, Inc. · Jul 2022
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
K210234 · Roche Molecular Systems, Inc. · Feb 2021