Cleared Traditional

Solana C. difficile Assay

K170491 · Quidel Corporation · Microbiology

May 2017

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K170491 is an FDA 510(k) clearance for the Solana C. difficile Assay, a C. Difficile Toxin Gene Amplification Assay (Class II — Special Controls, product code OZN), submitted by Quidel Corporation (Athens, US). The FDA issued a Cleared decision on May 11, 2017, 83 days after receiving the submission on February 17, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3130.

Submission Details

510(k) Number	K170491 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2017
Decision Date	May 11, 2017
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OZN — C. Difficile Toxin Gene Amplification Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3130
Definition	Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients.