Cleared Traditional

DENV Detect NS1 ELISA

K181473 · InBios International, Inc. · Microbiology

Aug 2018

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K181473 is an FDA 510(k) clearance for the DENV Detect NS1 ELISA, a Dengue Virus Antigen Assay (Class II — Special Controls, product code QCU), submitted by InBios International, Inc. (Seattle, US). The FDA issued a Cleared decision on August 27, 2018, 84 days after receiving the submission on June 4, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3945.

Submission Details

510(k) Number	K181473 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2018
Decision Date	August 27, 2018
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	QCU — Dengue Virus Antigen Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3945
Definition	Qualitative Detection Of Dengue Virus Antigen In Human Serum Or Plasma Collected From Human Patients With Signs And Symptoms Consistent With Dengue Virus Infection