Hemanext ONE
Device Facts
| Record ID | BK251294 |
|---|---|
| Device Name | Hemanext ONE |
| Applicant | Hemanext Inc. Lexington, MA 02421 |
| Product Code | QYC · Hematology |
| Decision Date | Mar 6, 2026 |
| Decision | SESE |
| Regulation | 21 CFR 864.9115 |
| Device Class | Class 2 |
Indications for Use
Blood container set used to process and store CP2D/AS-3 or ACD-A/AS-3 Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced. The Hemanext ONE system limits O2 and CO2 levels in the storage environment. Hemanext ONE is intended to process the following: - Whole Blood or Apheresis Derived CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 8-hours of collection. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 12 hours of collection. - Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 8-hours of collection. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 12 hours of collection. - Whole Blood or Apheresis Derived CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 30 hours of collection at 1-6°C. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection. - Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 30 hours of collection at 1-6°C. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection. - Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have undergone in-line filtration and have been stored at 1-6°C for up to 67 hours. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection. The Red Blood Cells must be processed with the Hemanext ONE system at room temperature (20-26°C). Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced may be stored for up to 42 days at 1-6°C. The Hemanext ONE system is used for volumes no greater than 350 mL of LR RBC.
Device Story
Hemanext ONE is a blood storage system comprising an Oxygen Reduction Bag (ORB) and a Hemanext Storage Bag (HSB). It processes leukocyte-reduced red blood cells (LR RBC) to create a low O2/CO2 environment. LR RBCs are transferred to the ORB via sterile docking; the system is placed on an agitator at room temperature (20-26°C). Agitation creates a thin layer of RBCs, facilitating oxygen release through the bag material into a sorbent-lined, O2/CO2-depleted space. Deoxygenated RBCs are then transferred to the HSB for storage. The HSB maintains the low-gas environment for up to 42 days. The device is transfusion-ready. It benefits patients by preserving RBC quality through reduced oxidative stress during storage.
Clinical Evidence
Bench testing only. In vitro studies evaluated hemolysis (acceptance: ≤ 1% at day 42, 95% confidence) and oxygen saturation (SO2 < 20% at 80% confidence/reliability; < 30% for 100% of units). Testing included sterilization, endotoxin, shelf-life, container closure integrity, biocompatibility (leachables/toxicologic risk assessment), and mechanical performance.
Technological Characteristics
System consists of two disposables: Oxygen Reduction Bag (ORB) and Hemanext Storage Bag (HSB). Utilizes sorbent-based gas reduction technology to create O2/CO2-depleted environment. Operates via gravity transfer and mechanical agitation (20-26°C). Materials evaluated for biocompatibility and leachable substances. Sterilization and container closure integrity validated.
Indications for Use
Indicated for processing and storage of leukocyte-reduced red blood cell (LR RBC) units (CP2D/AS-3 or ACD-A/AS-3) to reduce O2 and CO2 levels. Applicable to volumes ≤ 350 mL. Storage duration up to 42 days at 1-6°C.
Regulatory Classification
Identification
A container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions is a device intended for medical purposes that is used to process and store Red Blood Cell components and reduce oxygen levels in the storage environment.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use of the device must specify: (i) The Red Blood Cell components that can be processed and stored including acceptable anticoagulants and additive solutions; (ii) The hold time after Red Blood Cell component collection; (iii) The processing capacity (volume) of the device; and (iv) The storage temperature and dating period of processed Red Blood Cell components. (2) Studies must demonstrate that the device is biocompatible and include detailed documentation of the biocompatibility evaluation. (3) Performance testing and nonclinical studies must include a detailed study of leached materials extracted under conditions similar to clinical usage of the device, and a toxicologic risk assessment of those extracted or leached materials. (4) Performance testing must support sterility of the device and include sterilization validation, endotoxin testing, and container closure integrity evaluation. (5) Nonclinical and clinical studies must include evaluation of red blood cell quality throughout the duration of storage based on in vitro and in vivo studies, including hemolysis and red blood cell survival and recovery. (6) Performance studies must include: (i) Detailed documentation of functional and mechanical testing, including evaluation of oxygen and, if applicable, carbon dioxide levels during Red Blood Cell components storage; and (ii) Detailed documentation of device shelf-life testing demonstrating continued sterility, package integrity, and functionality over the identified shelf life. (7) The labeling must include a contraindication against processing Red Blood Cell components collected from donors with hemoglobin S.
Predicate Devices
- Hemanext ONE (BR220665)
