Cleared Traditional

VIDAS B.R.A.H.M.S. PCT (PCT)

K160911 · bioMerieux, Inc. · Microbiology
Jun 2016
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K160911 is an FDA 510(k) clearance for the VIDAS B.R.A.H.M.S. PCT (PCT), a Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens (Class II — Special Controls, product code PMT), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on June 28, 2016, 88 days after receiving the submission on April 1, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number K160911 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2016
Decision Date June 28, 2016
Days to Decision 88 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.