Cleared Special

K100227 - SAS FLUALERT A&B

K100227 is the FDA 510(k) clearance for SAS FLUALERT A&B by Sa Scientific, Inc.. It is a Class 2 Microbiology device (product code PSZ) cleared through the Special 510(k) pathway after a 28-day FDA review.

K100227 · Sa Scientific, Inc. · Microbiology device
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Feb 2010
Decision
28d
Days
Class 2
Risk

K100227 is an FDA 510(k) clearance for the SAS FLUALERT A&B, SAS INFLUENZA A TEST. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on February 23, 2010 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 Sa Scientific, Inc. devices

Submission Details

510(k) Number K100227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2010
Decision Date February 23, 2010
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 43
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K100227.
BIOSIGN FLU A+B
K083746 · Princeton BioMeditech Corp. · Nov 2010
BD DIRECTIGEN EX FLU A+B
K101461 · Becton, Dickinson and Company · Jun 2010
BD DIRECTIGEN EZ FLU A+B ASSAY
K101529 · Becton, Dickinson & CO · Jun 2010
QUICKVUE INFLUENZA A+B TEST
K092698 · Quidel Corp. · Sep 2009
XPECT FLU A & B
K092423 · Thermo Fisher Scientific · Aug 2009
SAS INFLUENZA A & B TEST
K080380 · Sa Scientific, Inc. · Jul 2009