Cleared Traditional

Lumipulse G B?R?A?H?M?S PCT Immunoreaction Cartridges, Lumipulse G B?R?A?H?M?S PCT Calibrators set

K172713 · Fujirebio Diagnostics,Inc. · Microbiology

Dec 2017

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K172713 is an FDA 510(k) clearance for the Lumipulse G B?R?A?H?M?S PCT Immunoreaction Cartridges, Lumipulse G B?R?A?H?M?S PCT Calibrators set, a Procalcitonin Assay (Class II — Special Controls, product code PRI), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on December 10, 2017, 93 days after receiving the submission on September 8, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number	K172713 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2017
Decision Date	December 10, 2017
Days to Decision	93 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).