Cleared Traditional

BD MAX GBS ASSAY, BD MAX INSTRUMENT

K111860 · Becton, Dickinson & CO · Microbiology

Feb 2012

Decision

231d

Days

Class 1

Risk

About This 510(k) Submission

K111860 is an FDA 510(k) clearance for the BD MAX GBS ASSAY, BD MAX INSTRUMENT, a Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (Class I — General Controls, product code NJR), submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on February 16, 2012, 231 days after receiving the submission on June 30, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K111860 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2011
Decision Date	February 16, 2012
Days to Decision	231 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.