BK230825 · Fresenius Kabi AG Lake Zurich, IL · GKT · Apr 5, 2024 · Hematology
Device Facts
Record ID
BK230825
Device Name
ALYX 2RBC-LR Kit
Applicant
Fresenius Kabi AG Lake Zurich, IL
Product Code
GKT · Hematology
Decision Date
Apr 5, 2024
Decision
SESE
Regulation
21 CFR 864.9245
Device Class
Class 2
Indications for Use
The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components. Depending on the ALYX Component Collection system apheresis kit used in the collection of products, the ALYX Component Collection system has been cleared for: Concurrent collection of two units of Red Blood Cells (2RBC), Leukocytes Reduced Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted Concurrent collection of two units of Red Blood Cells (2RBC), Non-Leukocytes Reduced Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted Concurrent collection of One Unit of Red Blood Cells, Leukocytes Reduced, and Plasma as: Fresh Frozen Plasma Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy. Source Plasma Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at -18°C or colder within 24 hours after phlebotomy. Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24) Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18°C or colder within 24 hours after phlebotomy Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. Collection of Plasma as: Fresh Frozen Plasma Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy. Source Plasma Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at -18°C or colder within 24 hours after phlebotomy. Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24) Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18°C or colder within 24 hours after phlebotomy. Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
Device Story
ALYX 2RBC-LR Kit is a sterile, single-use apheresis disposable kit; used with ALYX instrument; part of ALYX Component Collection System. System utilizes continuous-flow centrifugal separation to process whole blood into components. Kit includes fluid path, connectors, bags, and leukoreduction filter. Operated by trained personnel in blood collection establishments. Device separates whole blood into red blood cells and plasma; filter removes leukocytes. Output is collected blood components for clinical use. Modification involves substitution of leukoreduction filter component. Benefits include efficient collection of multiple blood products via automated process.
Clinical Evidence
Pivotal clinical study conducted in adults to evaluate the equivalence of the new leukoreduction filter to the current filter for the ALYX 2RBC-LR collection procedure. Primary and secondary endpoints met, providing evidence that the efficacy of the alternate filter is substantially equivalent to the predicate.
Technological Characteristics
Continuous-flow centrifugal blood cell separator. Single-use sterile fluid path kit including tubing, connectors, collection bags, and leukoreduction filter. System is an automated electromechanical instrument. No changes to fundamental technology or materials; modification limited to filter component substitution.
Indications for Use
Indicated for use in blood collection establishments for the collection and separation of whole blood into components, including leukoreduced or non-leukoreduced red blood cells and various plasma products (Fresh Frozen, Source, PF24, PF24RT24) in adult populations.
Regulatory Classification
Identification
An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.
Special Controls
*Classification.* Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”
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Fresenius Kabi
Three Corporate Drive
Lake Zurich, Illinois 60047
T 847-550-2300
T 888-391-6300
www.fresenius-kabi.us
## 510(k) SUMMARY
### Date Prepared
24 March 2023
### Owner/Operator
Owner/Operator# 9027285
Fresenius Kabi AG
Else-Kroner-Str. 1
61352 Bad Homburg, Germany
### Contact Person
| **Submission Contact** | Shane T. Sawall, RAC |
| --- | --- |
| **Title** | Senior Manager, Regulatory Affairs |
| **Address** | Three Corporate Drive Lake Zurich, IL 60047 |
| **Phone** | 847 550 0702 |
| **Fax** | 847 550 2960 |
| **Email** | shane.sawall@fresenius-kabi.com |
| **Official Correspondent** | Cheryl Roscher, Ph. D. |
| **Title** | Vice President, Regulatory Affairs and Laboratory Sciences |
| **Address** | Three Corporate Drive Lake Zurich, IL 60047 |
| **Phone** | 847 550 7909 |
| **Fax** | 847 550 2960 |
| **Email** | cheryl.roscher@fresenius-kabi.com |
### Device Trade Name
ALYX 2RBC-LR Kit
### Common Name/Usual Name:
Automated Blood Cell Separator / Centrifugal Separation Principle
### Other Marketing Names
ALYX Component Collection System ALYX ALYX System
### Classification Name
21 CFR 864.9245 Automated Blood Cell Separators
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Confidential
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FRESENIUS KABI
Fresenius Kabi
Three Corporate Drive
Lake Zurich, Illinois 60047
T 847-550-2300
T 888-391-6300
www.fresenius-kabi.us
Automated blood cell separators which are based on centrifugation type technology have been classified by the Center for Biologics Evaluation and Research as Class II devices with Special Controls (Docket 2005N-0017, Final Rule, 30-Nov-07; updated March 2011 OMB Control No. 0910-0594).
### **Product Code and Classification Panel**
81 GKT, Hematology Panel
### **Legally Marketed Device under which Substantial Equivalence is Being Claimed**
Fresenius Kabi is claiming the modified ALYX 2RBC-LR kit is substantially equivalent to and has the same intended use as the ALYX 2RBC-LR kit most recently cleared for market under BK200475 on 06/10/2020.
### **Device Description**
The ALYX 2RBC-LR Kit is an apheresis kit designed for use with the ALYX instrument as part of the ALYX Component Collection System, which is a continuous-flow, centrifugal device system that separates whole blood into its components. The ALYX 2RBC-LR Kit is a sterile fluid path, single-use apheresis kit that consists of attached solutions, connectors, filter, and bags, for the collection of two leukoreduced red blood cell products by centrifugation.
### **Statement of Intended Use / Indications for Use**
The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components.
Depending on the ALYX Component Collection system apheresis kit used in the collection of products, the ALYX Component Collection system has been cleared for:
- Concurrent collection of two units of Red Blood Cells (2RBC), Leukocytes Reduced
- Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted
- Concurrent collection of two units of Red Blood Cells (2RBC), Non-Leukocytes Reduced
- Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted
- Concurrent collection of One Unit of Red Blood Cells, Leukocytes Reduced, and Plasma as:
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Confidential
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FRESENIUS KABI
Fresenius Kabi
Three Corporate Drive
Lake Zurich, Illinois 60047
T 847-550-2300
T 888-391-6300
www.fresenius-kabi.us
- Fresh Frozen Plasma
- Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy.
- Source Plasma
- Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
- Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at -18°C or colder within 24 hours after phlebotomy.
- Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
- Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24)
- Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18°C or colder within 24 hours after phlebotomy
- Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
- Collection of Plasma as:
- Fresh Frozen Plasma
- Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy.
- Source Plasma
- Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
- Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at -18°C or colder within 24 hours after phlebotomy.
- Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
- Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24)
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Confidential
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FRESENIUS KABI
Fresenius Kabi
Three Corporate Drive
Lake Zurich, Illinois 60047
T 847-550-2300
T 888-391-6300
www.fresenius-kabi.us
- Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18°C or colder within 24 hours after phlebotomy.
- Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
### Technological Comparison as Compared to the Predicate Device
The technological characteristics of the proposed 2RBC-LR Kit remain the same as the predicate ALYX 2RBC-LR disposable kit. The proposed kit and predicate kit have the same performance characteristics and intended use. A modification to the 2RBC-LR Kit to enable the use of a functionally equivalent filter, subject of this 510(k), does not add, delete, or modify the technological characteristics of the disposable kit.
### Modification to the Existing Device
This application is being submitted for a change to the leukoreduction filter component in the existing ALYX 2RBC-LR Kit. There are no other changes that are subject of this 510(k) application.
### Performance Data
Testing was performed to demonstrate that the ALYX 2RBC-LR Kit with the alternate leukoreduction filter component meets existing specifications. The results of the testing were acceptable and demonstrate equivalence between the predicate kit and the proposed kit.
### Clinical Data
Fresenius Kabi conducted a pivotal study to evaluate the equivalence of the new filter to that of the current ALYX 2RBC-LR kit filter for the indication of the ALYX 2RBC-LR collection procedure in adults.
Primary and secondary endpoint evaluations provided evidence that the efficacy of the alternate filter was substantially equivalent to the current filter.
### Conclusion
The fundamental scientific technology, intended use, safety and effectiveness of the modified ALYX 2RBC-LR Kit remain unchanged. The verification testing performed and clinical study conducted in support of the change described in this application provide evidence that the proposed device is substantially equivalent to the predicate device.
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Confidential
