Cleared Traditional

Access PCT, Access PCT Calibrators

K192271 · Beckman Coulter, Inc. · Microbiology

Nov 2019

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K192271 is an FDA 510(k) clearance for the Access PCT, Access PCT Calibrators, 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 Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on November 26, 2019, 96 days after receiving the submission on August 22, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number	K192271 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 2019
Decision Date	November 26, 2019
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

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