BK251289 · Fresenius Kabi AG Lake Zurich, IL 60047 · GKT · Mar 31, 2026 · Hematology
Device Facts
Record ID
BK251289
Device Name
Plasmacell-C Disposable Set
Applicant
Fresenius Kabi AG Lake Zurich, IL 60047
Product Code
GKT · Hematology
Decision Date
Mar 31, 2026
Decision
SESE
Regulation
21 CFR 864.9245
Device Class
Class 2
Indications for Use
The Plasmacell-C Disposable Set is intended for collection of plasma by membrane filtration.
Device Story
Disposable set for automated blood cell separation; includes separation device, reservoir, tubing, and connectors. Used with Autopheresis-C and Aurora Plasmapheresis systems. Operates via spinning membrane filtration to separate whole blood into concentrated cellular components and plasma. Cellular components returned to donor; plasma collected for Source Plasma processing. Used in clinical/collection settings by trained operators. System facilitates rapid plasma collection; benefits include efficient donor processing and plasma yield.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing and verification activities in accordance with ISO 10993-1:2018 and established design requirements.
Technological Characteristics
Self-contained disposable set; includes separation device, reservoir, tubing, and connectors. Principle: spinning membrane filtration. Sterilization: radiation (sterile fluid path).
Indications for Use
Indicated for collection of plasma via membrane filtration from donors for use as Source Plasma.
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**
**Fresenius Kabi**
Three Corporate Drive
Lake Zurich, Illinois 60047
T 847-550-2300
T 888-391-6300
www.fresenius-kabi.us
March 26, 2026
## 510(k) Summary
### Contact Details
| **Applicant Name** | Fresenius Kabi AG |
| --- | --- |
| **Applicant Address** | Else-Kröner-Str. 1 Bad Homburg 61352 Germany |
| **Correspondent Name** | Fresenius Kabi |
| **Correspondent Address** | Three Corporate Drive Lake Zurich IL 60047 United States |
| **Correspondent Contact Telephone** | 847-550-2280 |
| **Correspondent Contact** | Shuiquan Jing |
| **Correspondent Contact Email** | shuiquan.jing@fresenius-kabi.com |
### Device Name
| **Device Trade Name** | Plasmacell-C Disposable Set |
| --- | --- |
| **Common Name** | Automated blood cell separator |
| **Classification Name** | Separator, Automated, Blood Cell, Diagnostic |
| **Regulation Number** | 864.9245 |
| **Product Code** | GKT |
### Legally Marketed Predicate Devices
| **Predicate 510(k) Number** | BK110072 |
| --- | --- |
| **Predicate Trade Name** | Plasmacell-C Disposable Set |
| **Product Code** | GKT |
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## Device Description Summary
The Plasmacell-C Disposable Set is a self-contained processing system intended for the collection of plasma by membrane filtration. Collected plasma can be used as Source Plasma. The disposable set consists of a separation device, a reservoir, tubing set and connectors. The disposable set is sterilized by radiation to achieve a sterile fluid path.
The Plasmacell-C Disposable Sets are used with Autopheresis-C and Aurora Plasmapheresis systems to achieve a rapid separation of whole blood into concentrated cellular components and plasma by means of spinning membrane filter. The concentrated cellular components are returned to the donor, and the collected plasma can be processed as Source Plasma.
## Intended Use/Indications for Use
The Plasmacell-C Disposable Set is intended for collection of plasma by membrane filtration.
## Indications for Use Comparison
The indications for use of the Plasmacell-C Disposable Set is the same as the predicate device.
## Technological Comparison
The modified Plasmacell-C Disposable Set has the same performance characteristics, the same components as the predicate device. The changes described in this application did not affect the fundamental scientific technology or principle of operation of the device.
## Non-Clinical and/or Clinical Tests Summary & Conclusions
The proposed product modifications have been evaluated in accordance with the test methods specified in ISO 10993-1:2018. Functional testing was conducted in alignment with the established product design requirements. The results of these assessments confirmed that the proposed changes do not adversely affect the product’s safety or effectiveness.
Clinical testing is not applicable.
The results of all verification activities demonstrated that the modified Plasmacell-C Disposable Set is substantially equivalent to the predicate device.
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