K181599 is an FDA 510(k) clearance for the Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3215. 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..
| 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 |
| 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. |