Cleared Traditional

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application (K181599) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence.

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

K181599 is an FDA 510(k) clearance for the Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application. Classified as Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment (product code QFS), Class II - Special Controls.

Submitted by Beckman Coulter (Miami, US). The FDA issued a Cleared decision on March 18, 2019 after a review of 273 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3215 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter devices

Submission Details

510(k) Number K181599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 102d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QFS Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03145428 Completed Observational Industry-sponsored

Evaluation of Monocyte Volume Distribution Width (MDW) for Early Detection of Sepsis

Evaluation of Monocyte Volume Width Distribution (MDW) for Early Detection of Sepsis or Developing Sepsis on the UniCell DxH800 Hematology Analyzer

3000
Patients (actual)
3
Sites
Condition studied Sepsis; Severe Infection
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Beckman Coulter, Inc. (industry)
Started 2017-06-19 → Primary completion 2017-12-22 → Completed 2018-01-26
Primary outcome
Identification of sepsis vs. non-sepsis, including SIRS and infection (non-SIRS) by adjudication based on the 2001 SCCM sepsis definition (sepsis-2)
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov