Cleared Traditional

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

K220262 · Siemens Healthcare Diagnostics, Inc. · Microbiology

Aug 2022

Decision

207d

Days

Class 2

Risk

About This 510(k) Submission

K220262 is an FDA 510(k) clearance for the Dimension EXL LOCI BRAHMS Procalcitonin (PCT), a Procalcitonin Assay (Class II — Special Controls, product code PRI), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on August 26, 2022, 207 days after receiving the submission on January 31, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number	K220262 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2022
Decision Date	August 26, 2022
Days to Decision	207 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).