Cleared Traditional

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

K181599 · Beckman Coulter · Microbiology
Mar 2019
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K181599 is an FDA 510(k) clearance for the Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application, a Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment (Class II — Special Controls, product code QFS), submitted by Beckman Coulter (Miami, US). The FDA issued a Cleared decision on March 18, 2019, 273 days after receiving the submission on June 18, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number K181599 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2018
Decision Date March 18, 2019
Days to Decision 273 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QFS — Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3215
Definition An Elevated Monocyte Distribution Width (mdw) Value, Together With Other Laboratory Findings And Clinical Information, Aids In Identifying Patients With Sepsis Or At Increased Risk Of Developing Sepsis Following Hospital Admission. Mdw Should Not Be Used As The Sole Basis To Determine The Absence Of Sepsis.