Cleared Traditional

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

K202755 · Diasorin Molecular, LLC · Microbiology

Nov 2022

Decision

775d

Days

Class 2

Risk

About This 510(k) Submission

K202755 is an FDA 510(k) clearance for the Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack, a Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection (Class II — Special Controls, product code QDZ), submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on November 5, 2022, 775 days after receiving the submission on September 21, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3181.

Submission Details

510(k) Number	K202755 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2020
Decision Date	November 05, 2022
Days to Decision	775 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QDZ — Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3181
Definition	The Device Is A Qualitative, In Vitro Diagnostic Test For The Direct Detection Of Cytomegalovirus (cmv) Dna In Saliva From Newborn Babies.