Cleared Traditional

Elecsys BRAHMS PCT

K192815 · Roche Diagnostics · Microbiology

Mar 2020

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K192815 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 March 9, 2020, 160 days after receiving the submission on October 1, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number	K192815 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 01, 2019
Decision Date	March 09, 2020
Days to Decision	160 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).