NexSys PCS® Plasma Collection System with Persona Plus Technology

BK251292 · Haemonetics Corporation Boston, MA 02110 · GKT · Feb 20, 2026 · Hematology

Device Facts

• Record ID: BK251292
• Device Name: NexSys PCS® Plasma Collection System with Persona Plus Technology
• Applicant: Haemonetics Corporation Boston, MA 02110
• Product Code: GKT · Hematology
• Decision Date: Feb 20, 2026
• Decision: SESE
• Regulation: 21 CFR 864.9245
• Device Class: Class 2

Indications for Use

The NexSys PCS® plasma collection system with Persona or Persona PLUS Technology is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation. Products that can be collected using the NexSys PCS® system include source plasma and plasma for transfusion. Using the 0625Q-00 bowl, the NexSys PCS® system with Express®Plus Technology is intended to collect source plasma only.

Device Story

Automated blood cell separator; uses centrifugation to separate whole blood into plasma and remaining components; returns components to donor. Operated in plasma collection centers by trained personnel. Persona PLUS Technology optimizes plasma collection. System utilizes single-use sterile disposable sets. Output is collected plasma for therapeutic transfusion or source plasma for fractionation. Clinical decision-making supported by automated system monitoring; benefits include efficient, standardized plasma collection.

Clinical Evidence

Prospective, randomized, controlled, multicenter pivotal clinical trial conducted to evaluate safety and effectiveness of NexSys PCS with Persona PLUS Technology. Results demonstrate no change to benefit-risk profile compared to predicate devices; device is as safe and effective as predicates.

Technological Characteristics

Automated blood cell separator; centrifugation-based separation; uses single-use sterile disposable sets; includes Persona PLUS Technology; no changes to materials, composition, or energy source from predicate.

Indications for Use

Indicated for use as an automated cell separator and blood component collector for the collection of source plasma and plasma for transfusion from donors.

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.”

Predicate Devices

• NexSys PCS Plasma Collection System with Express®Plus Technology (BK220798)
• NexSys PCS Plasma Collection System with Persona Technology (BK200498)

Submission Summary (Full Text)

{0}

# HAEMONETICS®

## 510(k) Summary

**Date:** February 18, 2026

# **Submitter:**

Haemonetics Corporation
125 Summer Street
Boston, MA 02110

# **Contact:**

Amy Tannenbaum
Manager, Regulatory Affairs
Phone: [phone]
Email: [e-mail]

# **Device Information:**

*Trade Name:* NexSys PCS® Plasma Collection System with Persona PLUS Technology
*Common Name:* Automated Blood Cell Separator
*Classification Name:* Separator, Automated, Blood Cell, Diagnostic
*Regulation Number:* 21 CFR 864.9245
*Review Panel:* Hematology
*Product Code:* GKT
*Device Class:* 2

# **Legally Marketed Predicate Device:**

| Predicate # | Predicate Trade Name | Product Code |
| --- | --- | --- |
| BK220798 | NexSys PCS Plasma Collection System with Express®Plus Technology | GKT |
| BK200498 | NexSys PCS Plasma Collection System with Persona Technology | GKT |

# **Device Description Summary:**

The Haemonetics NexSys PCS® Plasma Collection System is designed for separation of whole blood by centrifugation, collection of plasma, and return of the remaining components to the donor. The plasma may be designated for use in therapeutic transfusion or be conserved and used as source plasma, that is subsequently fractioned into plasma-derived products.

---Haemonetics Corporation | 125 Summer Street | Boston, MA 02110

{1}

# HAEMONETICS®

## Intended Use/Indications for Use:

The NexSys PCS® plasma collection system with Persona or Persona PLUS Technology is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation.

Products that can be collected using the NexSys PCS® system include source plasma and plasma for transfusion.

Using the 0625Q-00 bowl, the NexSys PCS® system with Express®Plus Technology is intended to collect source plasma only.

## Indications for Use Comparison:

There is no change to the indications for use of the NexSys PCS® Plasma Collection System with Persona PLUS Technology from its predicate device.

## Technological Comparison:

There is no change to the material, composition, principle of operation, or energy source from the predicate NexSys PCS® (BK220798). The device functions with the same intended use for the collection of plasma via apheresis.

There is no change to software of the product specific to this change to introduce Persona PLUS Technology.

Through the discussion on substantial equivalence and the clinical data provided, it is concluded that the changes associated with the NexSys PCS do not change the benefit-risk profile of the NexSys PCS device.

## Non-Clinical Summary & Conclusions

There was no new non-clinical testing required.

## Clinical Summary & Conclusions

A prospective, randomized, controlled, multicenter, pivotal clinical trial to evaluate the safety and effectiveness of the NexSys PCS with Persona PLUS Technology was conducted. Through the clinical data provided, it is demonstrated that there is no change to the benefit-risk profile of the NexSys PCS device with the introduction of the Persona PLUS Technology. The proposed device is as safe and effective as its predicate and reference device.

---Haemonetics Corporation | 125 Summer Street | Boston, MA 02110