510(k) K170940

Rickettsia Real-time PCR Assay by Centers For Disease Control and Prevention (Cdc) — Product Code PVQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 29, 2017
Date Received: March 30, 2017
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Rickettsia Spp. Nucleic Acid Based Detection Assay
Device Class: Class II
Regulation Number: 866.3316
Review Panel: MI
Submission Type

An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in 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)
DEN160016 — Variola virus Real-Time PCR Assay (February 6, 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)