Cleared Traditional

ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

K191578 · Siemens Healthcare Diagnostics, Inc. · Microbiology
Jul 2019
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K191578 is an FDA 510(k) clearance for the ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control, a Zika Virus Serological Reagents (Class II — Special Controls, product code QFO), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on July 17, 2019, 33 days after receiving the submission on June 14, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3935.

Submission Details

510(k) Number K191578 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2019
Decision Date July 17, 2019
Days to Decision 33 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.