Cleared Traditional

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

K160729 · Roche Diagnostics · Microbiology
Jun 2016
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K160729 is an FDA 510(k) clearance for the Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5, a Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens (Class II — Special Controls, product code PMT), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on June 13, 2016, 89 days after receiving the submission on March 16, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number K160729 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2016
Decision Date June 13, 2016
Days to Decision 89 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.