Cleared Traditional

Simplexa GBS Direct, Simplexa GBS Positive Control Pack

K182467 · Diasorin Molecular, LLC · Microbiology

Nov 2018

Decision

58d

Days

Class 1

Risk

About This 510(k) Submission

K182467 is an FDA 510(k) clearance for the Simplexa GBS Direct, Simplexa GBS Positive Control Pack, a Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (Class I — General Controls, product code NJR), submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on November 7, 2018, 58 days after receiving the submission on September 10, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K182467 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2018
Decision Date	November 07, 2018
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	NJR — Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device Class	Class I — General Controls
CFR Regulation	21 CFR 866.3740
Definition	A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Group B Streptococci From Pre-partum And Intra-partum Women To Establish Colonization Status.