Cleared Traditional

Atellica IM BRAHMS Procalcitonin (PCT)

K181002 · Siemens Healthcare Diagnostics, Inc. · Microbiology
Jul 2018
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K181002 is an FDA 510(k) clearance for the Atellica IM BRAHMS Procalcitonin (PCT), a Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens (Class II — Special Controls, product code PMT), submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on July 16, 2018, 91 days after receiving the submission on April 16, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number K181002 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2018
Decision Date July 16, 2018
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PMT — Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3215
Definition An Assay Used To Determine The Level Of Procalcitonin (pct) In Human Serum And Plasma As An Aid In Assessing The Mortality For Patients Diagnosed With Severe Sepsis Or Septic Shock.