Cleared Traditional

Access PCT

K222996 · Beckman Coulter, Inc. · Microbiology

Apr 2023

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K222996 is an FDA 510(k) clearance for the Access PCT, 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 April 26, 2023, 210 days after receiving the submission on September 28, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number	K222996 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2022
Decision Date	April 26, 2023
Days to Decision	210 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