Cleared Special

K153219 - ProFlu+ Assay

K153219 is the FDA 510(k) clearance for ProFlu+ Assay by Hologic, Inc.. It is a Class 2 Microbiology device (product code OCC) cleared through the Special 510(k) pathway after a 15-day FDA review.

K153219 · Hologic, Inc. · Microbiology device
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Nov 2015
Decision
15d
Days
Class 2
Risk

K153219 is an FDA 510(k) clearance for the ProFlu+ Assay. Classified as Respiratory Virus Panel Nucleic Acid Assay System (product code OCC), Class II - Special Controls.

Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Cleared decision on November 20, 2015 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hologic, Inc. devices

Submission Details

510(k) Number K153219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2015
Decision Date November 20, 2015
Days to Decision 15 days
Submission Type Special
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
87d faster than avg
Panel avg: 102d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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

All 22
Devices cleared under the same product code (OCC) and FDA review panel - the closest regulatory comparables to K153219.
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