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- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- BSAWarmer, Blood, Electromagnetic Radiation3Product Code
- BSBWarmer, Blood, Non-Electromagnetic Radiation2Product Code
- GKTSeparator, Automated, Blood Cell, Diagnostic2Product Code
- KSBSet, Transfer (Blood/Plasma)2Product Code
- KSDDevice, Heat-Sealing1Product Code
- KSERefrigerator, Freezer, Blood Storage2Product Code
- KSFKit, Quality Control For Blood Banking Reagents2Product Code
- KSGMedia, Potentiating For In Vitro Diagnostic Use2Product Code
- KSHChamber, Environmental For The Storage Of Platelet Concentrate2Product Code
- KSILectins And Protectins2Product Code
- KSKSolution, Stabilized Enzyme2Product Code
- KSLSolution, Copper Sulfate For Specific Gravity Determinations1Product Code
- KSMSystem, Test, Combs, Automated2Product Code
- KSNCentrifuge, Cell-Washing, Automated For Immuno-Hematology2Product Code
- KSOCentrifuge, Blood-Bank For In Vitro Diagnostic Use1Product Code
- KSPApparatus, Cell-Freezing And Reagents1Product Code
- KSQDevice, Blood Mixing And Blood Weighing1Product Code
- KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components2Product Code
- KSSSupplies, Blood-Bank1Product Code
- KSTSystem, Blood Collection, Vacuum-Assisted, Manual1Product Code
- KSWSystem, Processing For Frozen Blood2Product Code
- KSXSubstance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use2Product Code
- KSYBoxes, View, Blood Grouping1Product Code
- KSZSystem, Test, Automated Blood Grouping And Antibody2Product Code
- KZLDevice, Warming. Blood And Plasma2Product Code
- MMHBlood Establishment Computer Software And Accessories2Product Code
- MYJDevice, Mixing And Weighing, Semi-Automated2Product Code
- MYXSystem, Blood Collection, Vacuum-Assisted, Automated1Product Code
- OQXSelf-Contained Blood Grouping2Product Code
- ORGPlatelet And Plasma Separator For Bone Graft Handling2Product Code
- PBCManual Blood Grouping And Antibody Test Systems2Product Code
- PKGBone Marrow Processing Device To Support Hematopoietic Reconstitution2Product Code
- PMQPeripheral Blood Processing Device For Wound Management2Product Code
- QYCContainer System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions2Product Code
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
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Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions
- Page Type
- Product Code
- Definition
- The 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.
- Physical State
- Assembly of two components the Oxygen Reduction Bag (ORB) and the Storage Bag (HSB)
- Technical Method
- Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.
- Target Area
- Human clinical specimens
- Regulation Medical Specialty
- Hematology
- Review Panel
- Hematology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 864.9115
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
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CFR § 864.9115 Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions
§ 864.9115 Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.
(a) 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.
(b) 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.
[88 FR 77199, Nov. 9, 2023]