QFS — Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment Class II
FDA product code QFS covers "Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment", a Class II medical device regulated under 21 CFR 866.3215. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QFS
- Device Class
- Class II
- Regulation Number
- 866.3215
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K181599 | beckman coulter | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | March 18, 2019 |