DeviceClearance

Product code PTF— Microbiology

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Classification name
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Device class
Class 2
Regulation
21 CFR 866.3215
Advisory panel
Microbiology
Total cleared
4
First cleared
Most recent

FDA classification definition

“Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock”

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

Market context for product code PTF

FDA has cleared 4 devices under product code PTF between 2017 and 2025, filed by 3 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 PTF

Recent clearances under product code PTF

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