Non-Factor Replacement Product Test System
A non-factor replacement product test system is a prescription in vitro diagnostic device intended to measure non-factor replacement therapeutic products (used for routine prophylaxis in patients with bleeding disorders including hemophilia) in human blood specimens, ensuring that therapeutic drug levels are within the range specified in the approved product labeling for appropriate management. It is classified as FDA Class II (510(k) required) under regulation 864.7298 in the Hematology specialty, with product code SES. The device is not an implant and does not support life-sustaining functions.
Basic Information
- Product Code
- SES
- Device Class
- FDA class 2
- Regulation Number
- 864.7298
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
Definition
A non-factor replacement product test system is a prescription in vitro diagnostic device intended to measure non-factor replacement therapeutic products that are indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with bleeding disorders, including hemophilia, in human blood specimens to ensure appropriate therapy in accordance with the approved non-factor replacement product labeling.
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 |
|---|---|---|---|---|
| DEN240035 | ConcizuTrace ELISA | May 22, 2025 | Unknown | Randox Laboratories Ltd |
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.