Cleared Special

K181853 - Alere BinaxNOW Influenza A & B Card 2

K181853 is the FDA 510(k) clearance for Alere BinaxNOW Influenza A & B Card 2 by Alere Scarborough, Inc.. It is a Class 2 Microbiology device (product code PSZ) cleared through the Special 510(k) pathway after a 28-day FDA review.

K181853 · Alere Scarborough, Inc. · Microbiology device
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Aug 2018
Decision
28d
Days
Class 2
Risk

K181853 is an FDA 510(k) clearance for the Alere BinaxNOW Influenza A & B Card 2, Alere Reader. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Alere Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on August 8, 2018 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3328 - 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 Alere Scarborough, Inc. devices

Submission Details

510(k) Number K181853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2018
Decision Date August 08, 2018
Days to Decision 28 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
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3328
Definition An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection.
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 - PSZ Devices Detecting Influenza A, B, And C Virus Antigens

All 49
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K181853.
CareStart Flu A&B Plus
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BioSign Flu A+B
K182157 · Princeton BioMeditech Corp. · Sep 2018
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K180438 · Bd · Mar 2018
QuickVue Influenza A+B
K180288 · Quidel Corporation · Feb 2018
Sofia Influenza A+B FIA on Sofia 2
K162438 · Quidel Corporation · Apr 2017