# K162297: Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Apr 18, 2017 after 245 days
- Product code: PTF (Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission)
- Device class: 2
- Regulation: 21 CFR 866.3215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Diazyme PCT Assay is a latex particle enhanced immunoturbidimetric method intended for the quantitative determination of PCT in human serum, EDTA or lithium heparin plasma. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock. For in vitro diagnostic use only. The Diazyme PCT Calibrator Set is intended for use in the calibration of the Diazyme PCT Assay. For in vitro diagnostic use only. The Diazyme PCT Control Set is intended for use as quality control for the Diazyme PCT Assay. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K162297
Methodology: https://510kreport.com/methodology