Cleared Traditional

Elecsys BRAHMS PCT

K173927 · Roche Diagnostics · Microbiology

Jul 2018

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K173927 is an FDA 510(k) clearance for the Elecsys BRAHMS PCT, a Procalcitonin Assay (Class II — Special Controls, product code PRI), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on July 6, 2018, 192 days after receiving the submission on December 26, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number	K173927 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2017
Decision Date	July 06, 2018
Days to Decision	192 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PRI — Procalcitonin Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3215
Definition	To Aid In Decision Making On Antibiotic Therapy, Including Antibiotic Initiation And Discontinuation, For Inpatients Or Patients In The Emergency Department, With Suspected Or Confirmed Lower Respiratory Tract Infections (lrti) Defined As Community-acquired Pneumonia (cap), Acute Bronchitis, And Acute Exacerbation Of Chronic Obstructive Pulmonary Disease (aecopd).