Cleared Traditional

JBAIDS INFLUENZA A SUBTYPING KIT

K111778 · U.S Army Medical Materiel Development Activity · Microbiology

Sep 2011

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K111778 is an FDA 510(k) clearance for the JBAIDS INFLUENZA A SUBTYPING KIT, a 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification (Class II — Special Controls, product code OQW), submitted by U.S Army Medical Materiel Development Activity (Fort Detrick, US). The FDA issued a Cleared decision on September 13, 2011, 82 days after receiving the submission on June 23, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3332.

Submission Details

510(k) Number	K111778 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2011
Decision Date	September 13, 2011
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OQW — 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3332
Definition	2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens