DeviceClearance

Product code PMT— Microbiology

Atellica IM BRAHMS Procalcitonin (PCT)

Classification name
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Device class
Class 2
Regulation
21 CFR 866.3215
Advisory panel
Microbiology
Total cleared
5
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PMT under 21 CFR 866.3215, via openFDA

Market context for product code PMT

FDA has cleared 5 devices under product code PMT between 2016 and 2020, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PMT

Recent clearances under product code PMT

Data sourced from openFDA. This site is unofficial and independent of the FDA.