Cleared Traditional

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set

K192046 · DiaSorin, Inc. · Microbiology

Oct 2019

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K192046 is an FDA 510(k) clearance for the LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set, a Zika Virus Serological Reagents (Class II — Special Controls, product code QFO), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on October 28, 2019, 89 days after receiving the submission on July 31, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3935.

Submission Details

510(k) Number	K192046 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2019
Decision Date	October 28, 2019
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QFO — Zika Virus Serological Reagents
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3935
Definition	Zika Virus Serological Reagents Are Devices That Consist Of Antigens And Antisera For The Diagnosis Of Zika Virus Infection In Human Clinical Specimens From Individuals That Have Signs And Symptoms Consistent With Zika Virus Infection And/or Epidemiological Risk Factors. The Device Aids In The Presumptive Clinical Diagnosis Of Zika Virus Infection In Conjunction With Other Clinical And Laboratory Findings.