510(k) DEN160016

Variola virus Real-Time PCR Assay by Centers For Disease Control and Prevention (Cdc) — Product Code PRA

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: February 6, 2017
Date Received: April 14, 2016
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Variola Virus Nucleic Acid-Based Detection Assay
Device Class: Class II
Regulation Number: 866.3316
Review Panel: MI
Submission Type

The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection. The test results must be used in conjunction with other diagnostic assays and clinical observations, as an aid to the diagnosis of infection, in accordance with the criteria defined by the appropriate public health authorities with the Federal government.

Other clearances by Centers For Disease Control and Prevention (Cdc)

K181736 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage (July 30, 2018)
K170940 — Rickettsia Real-time PCR Assay (June 29, 2017)
K161556 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtypi (June 30, 2016)
K153148 — CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Sub (December 1, 2015)
K140426 — ANTHRACIS REAL-TIME PCR ASSAY (May 22, 2014)