Cleared Traditional

K041441 - SAS INFLUENZA A TEST

K041441 is the FDA 510(k) clearance for SAS INFLUENZA A TEST by Sa Scientific, Inc.. It is a Class 2 Microbiology device (product code PSZ) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K041441 · Sa Scientific, Inc. · Microbiology device
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Jul 2004
Decision
51d
Days
Class 2
Risk

K041441 is an FDA 510(k) clearance for the 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 July 22, 2004 after a review of 51 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sa Scientific, Inc. devices

Submission Details

510(k) Number K041441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2004
Decision Date July 22, 2004
Days to Decision 51 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
51d faster than avg
Panel avg: 102d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K041441.
QUICKVUE INFLUENZA A + B TEST
K053146 · Quidel Corp. · Dec 2005
BD DIRECTIGEN EZ FLU A + B
K042472 · Becton, Dickinson & CO · Jul 2005
SAS INFLUENZA B TEST
K041439 · Sa Scientific, Inc. · Jul 2004
QUICKVUE INFLUENZA A+B TEST
K031899 · Quidel Corp. · Sep 2003
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
K011684 · Roche Diagnostics Corp. · Nov 2001
BD DIRECTIGEN FLU A+B
K001364 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 2000