Cleared Traditional

LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers

K173683 · DiaSorin, Inc. · Microbiology

Feb 2018

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K173683 is an FDA 510(k) clearance for the LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers, a Procalcitonin Assay (Class II — Special Controls, product code PRI), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on February 27, 2018, 88 days after receiving the submission on December 1, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number	K173683 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 2017
Decision Date	February 27, 2018
Days to Decision	88 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).