PMTClass II

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

21 CFR 866.3215 / Microbiology

PMT is the FDA product code for Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens, a class II device type, regulated under 21 CFR 866.3215. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 2020-02-25, and one recall.

Classification record

Product code: PMT
Device name: Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
FDA 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.
Regulation: 21 CFR 866.3215
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 5
Ingested recalls: 1

Clearances, product code PMT

By decision year

5 clearances under product code PMT with a decision year between 2016 and 2020, 2016 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code PMT by decision year
Year	Clearances
2016	3
2018	1
2020	1

Applicants with the most clearances

Product code PMT

Applicants holding the most 510(k) clearances under product code PMT
Applicant	Clearances
B.R.A.H.M.S GmbH	1
Ortho-Clinical Diagnostics, Inc.	1
Roche Diagnostics GmbH	1
Siemens Healthcare Diagnostics Inc.	1
bioMerieux, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order