Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
The Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment is an in vitro diagnostic measurement where 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. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 866.3215 in the Microbiology specialty. The product code is QFS. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QFS
- Device Class
- FDA class 2
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | Mar 18, 2019 | Substantially Equivalent | Beckman Coulter |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.