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
| Device Type ID | 3595 |
| Device Name | Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment |
| Physical State | The Device Is An Analyzer Which Uses A Scatterplot Of Light Scatter Correlated To The Volume Of The Cells To Identify The Monocyte Population |
| Technical Method | Clinical Whole Blood Specimen Is Measured In An Automated Cellular Analyzer System |
| Target Area | Clinical Whole Blood Specimen |
| Regulation Description | Device To Detect And Measure Non-microbial Analyte(s) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3215 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QFS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3595 |
| Device | Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment |
| Product Code | QFS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Device To Detect And Measure Non-microbial Analyte(s) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis. |
| CFR Regulation Number | 866.3215 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |