Cleared Traditional

VITROS BRAHMS PCT Reagent Pack and Calibrators

K200236 · Ortho-Clinical Diagnostics · Microbiology
Feb 2020
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K200236 is an FDA 510(k) clearance for the VITROS BRAHMS PCT Reagent Pack and Calibrators, a Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens (Class II — Special Controls, product code PMT), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on February 25, 2020, 26 days after receiving the submission on January 30, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number K200236 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2020
Decision Date February 25, 2020
Days to Decision 26 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.