Cleared Traditional

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

K162297 · Diazyme Laboratories · Microbiology

Apr 2017

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K162297 is an FDA 510(k) clearance for the Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set, a Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission (Class II — Special Controls, product code PTF), submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on April 18, 2017, 245 days after receiving the submission on August 16, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number	K162297 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2016
Decision Date	April 18, 2017
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

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	Class II — Special Controls
CFR Regulation	21 CFR 866.3215
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