FDA product code QFS: Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
QFS is the FDA product code for monocyte distribution width quantitative measurement for sepsis risk assessment. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under QFS. The average 510(k) review took 273 days (median 273).
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.
Classification
| Field | Value |
|---|---|
| Device name | Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment |
| Device class | Class II |
| Regulation | 21 CFR 866.3215 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QFS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 273 |
Compare with all 510(k) review times · Search every QFS clearance
Top QFS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter | 1 | 2019-03-18 |
Most recent QFS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181599 | Beckman Coulter | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | 2019-03-18 | 273 |
Recalls for QFS devices
openFDA lists no recalls for product code QFS.
Frequently asked questions
What is FDA product code QFS?
QFS is the FDA product code for monocyte distribution width quantitative measurement for sepsis risk assessment. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel.
What device class is QFS?
Class II, regulation 21 CFR 866.3215. Typical premarket route: 510(k).
How long does a 510(k) take for product code QFS?
Across 1 cleared submissions the average was 273 days from receipt to decision (median 273).
Which companies have the most QFS clearances?
Beckman Coulter (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QFS
- Run a recall and safety report across every QFS manufacturer
- Watch product code QFS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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