Cleared Traditional

XPECT INFLUENZA A/B

K031565 · Remel, Inc. · Microbiology

Jul 2003

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K031565 is an FDA 510(k) clearance for the XPECT INFLUENZA A/B, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on July 17, 2003, 59 days after receiving the submission on May 19, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K031565 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2003
Decision Date	July 17, 2003
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PSZ — Devices Detecting Influenza A, B, And C Virus Antigens
Device Class	Class II — 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.