Device class
Class II
Regulation 866.3215
Total clearances
3
2022-12-20 → 2025-11-19
Definition
What is Deformability Cytometry For Sepsis Risk Assessment
A semi-quantitative assay that measures cellular deformability and other physical properties of leukocytes in whole blood samples to aid the early detection of sepsis
Classification details
Medical specialty
Microbiology
Regulation number
866.3215
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Cytovale, Inc.
|
3 |
1 |
2025-11-19 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 85059 |
CPT
|
— |
Medium
|
CPT for leukocyte differential count; related cellular analysis for sepsis risk assessment |
| 80053 |
CPT
|
— |
Low
|
Comprehensive metabolic panel; general sepsis/systemic inflammatory workup |
Pulse
Most recent 510(k) clearances