510(k) K181599
K181599 is an FDA 510(k) premarket notification submitted by Beckman Coulter for the device "Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application". The FDA issued a decision of Substantially Equivalent on March 18, 2019. The device falls under product code QFS (Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment), a Class II device regulated under 21 CFR 866.3215. Beckman Coulter has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2019
- Date Received
- June 18, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
- Device Class
- Class II
- Regulation Number
- 866.3215
- Review Panel
- MI
- Submission Type
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.