Cleared Traditional

BD Kiestra IdentifA

K191964 · Becton, Dickinson and Company · Microbiology

Nov 2021

Decision

834d

Days

Class 2

Risk

About This 510(k) Submission

K191964 is an FDA 510(k) clearance for the BD Kiestra IdentifA, a Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry (Class II — Special Controls, product code QQV), submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on November 3, 2021, 834 days after receiving the submission on July 23, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3378.

Submission Details

510(k) Number	K191964 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 2019
Decision Date	November 03, 2021
Days to Decision	834 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QQV — Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3378
Definition	An Automated In Vitro Diagnostic System To Prepare Colonies Of Microorganisms Grown On Solid Culture Media From Human Specimens For Qualitative Identification And Differentiation Using Matrix-assisted Laser Desorption/ionization-time Of Flight Mass Spectrometry (maldi-tof Ms).