FDA Product Code PTF: Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
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
Leading manufacturers include Beckman Coulter, Inc. and Diasys Diagnostic Systems GmbH.
FDA 510(k) Cleared Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission Devices (Product Code PTF)
About Product Code PTF - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PTF since 2017, with 4 receiving FDA clearance (average review time: 208 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under PTF have taken an average of 280 days to reach a decision - up from 184 days historically. Manufacturers should account for longer review timelines in current project planning.
PTF devices are reviewed by the Microbiology panel. Browse all Microbiology devices →