BK251168 · Arteriocyte Medical Systems, Inc. DBA Isto Biologics Hopkinton, MA 01748 · ORG · Feb 3, 2026 · Hematology
Device Facts
Record ID
BK251168
Device Name
Precise Cell Concentration System
Applicant
Arteriocyte Medical Systems, Inc. DBA Isto Biologics Hopkinton, MA 01748
Product Code
ORG · Hematology
Decision Date
Feb 3, 2026
Decision
SESE
Regulation
21 CFR 864.9245
Device Class
Class 2
Indications for Use
The Precise Cell Concentration System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a mixture of peripheral blood and bone marrow aspirate (BMA) at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.
Device Story
The Precise Cell Concentration System is a sterile, single-use kit for point-of-care preparation of autologous platelet-rich plasma (PRP). The system processes a mixture of peripheral blood and bone marrow aspirate (BMA). The user transfers the sample into a processing canister containing an internal buoy, which is then placed in a general-purpose centrifuge. Centrifugation (3000 G at 4400 RPM for 12 minutes) separates the sample by density; red blood cells are trapped under the buoy, while the buffy coat (platelets and white blood cells) and plasma are isolated. The clinician aspirates the resulting PRP through a swabable Luer valve. The PRP is then mixed with autograft or allograft bone to improve the handling characteristics of the graft material during surgical application to bony defects. The device benefits the patient by providing a rapid, standardized method for preparing autologous PRP at the point of care.
Clinical Evidence
Bench testing only. A study using healthy human donor samples compared PRP produced from a peripheral blood/BMA mixture against the predicate device. Metrics included platelet count, platelet fold, platelet yield, white blood cell count, red blood cell reduction, and platelet function (p-selectin expression, hypotonic stress response, pH). Results demonstrated substantial equivalence. A comparative study also assessed bone graft handling (cohesion) using PRP versus saline, showing improved handling with the device's PRP.
Technological Characteristics
Single-use kit comprising medical-grade polymers, elastomers, and stainless steel. Operates via density-based separation in a general-purpose centrifuge (3000 G, 4400 RPM, 12 minutes). Features a cylinder with an internal buoy. Sterilized via irradiation per ISO 11137-1:2006/(R)2015. Biocompatibility evaluated per ISO 10993-1. Capacity: 60 mL.
Indications for Use
Indicated for preparation of autologous platelet rich plasma (PRP) from a mixture of peripheral blood and bone marrow aspirate for mixing with bone graft to improve handling characteristics in patients requiring bone defect repair.
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.”
{0}
# 510(k) Summary
| Date Prepared: | January 30, 2026 |
| --- | --- |
| Submitter: | Arteriocyte Medical Systems, Inc. DBA Isto Biologics 45 South Street, Hopkinton, MA 01748 USA |
| Contact Person: | Tenzin Choezom Regulatory Affairs Manager (b) (6) Fax: 508-497-8974 Email: tchoezom@istobiologics.com |
| Subject Device: | Precise Cell Concentration System |
| Regulation Number: | 21 CFR 864.9245 |
| Regulation Name: | Automated blood cell separator |
| Regulatory Class: | II |
| Predicate Device: | Precise Cell Concentration System |
## Indication for Use:
The Precise Cell Concentration System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a mixture of peripheral blood and bone marrow aspirate (BMA) at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.
## Device Description
The Precise Cell Concentration System is a sterile, single-use kit comprising blood collection components, syringes, and the components necessary to process a mixture of peripheral blood and BMA samples. The sample collected is transferred to the processing cannister and placed into a general-purpose centrifuge. After centrifugation, the desired amount of PRP is isolated in the syringe. The device is built of medical-grade polymers, elastomer, and stainless steel, suitable for use in medical devices.
## Technological Characteristics and Substantial Equivalence
The fundamental scientific technology, principles of operation, materials of construction, sterility assurance level, and biocompatibility are exactly the same between the subject Precise Cell Concentration System and the predicate device, BK200540. There are no technological characteristics that raise new issues of safety or effectiveness for how the cell concentration is generated compared with the Precise Cell Concentration System. Both the subject and predicate devices process 60 mL of anticoagulated samples. Both devices require the use of a general
Arteriocyte Medical Systems, Inc.
Traditional 510(k) Application
Page 1 of 3
{1}
centrifuge to separate the sample into layers based on cell density. The bottom layer generated is red blood cells (RBC), and above that is a buffy coat layer (white blood cells and platelets) and plasma. The RBCs are trapped under the buoy system within the Precise cannister. The buffy coat layer mixed with a small amount of plasma constitutes the final product. The following outlines the comparison of technological characteristics between the subject Precise Cell Concentration System and the predicate Precise Cell Concentration System.
| Point of Comparison | Predicate Device- Precise Cell Concentration System – BK200450 | Subject Device- Precise Cell Concentration System - BK251168 |
| --- | --- | --- |
| Indication for Use | The Precise Cell Concentration System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics. | The Precise Cell Concentration System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a mixture of peripheral blood and bone marrow aspirate (BMA) at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics. |
| System Components | Disposable concentrating device packaged with syringes, blood draw needles, blood draw accessories, and ACD-A anticoagulant. | Disposable concentrating device packaged with syringes, blood draw needles, blood draw accessories, and ACD-A anticoagulant. |
| Device Material | Medical grade polymers, elastomers and stainless steel suitable for use in medical devices. | Medical grade polymers, elastomers and stainless steel suitable for use in medical devices. |
| Principles of Operation/ Method of Fluid Separation | Separation of blood based on density. | Separation of blood and bone marrow aspirate based on density. |
| Device Structure | Cylinder with internal buoy | Cylinder with internal buoy |
| Method of Processing | Centrifugation | Centrifugation |
| Centrifuge Device | General purpose centrifuge | General purpose centrifuge |
| RCF | 3000 G | 3000 G |
| RPM | 4400 | 4400 |
| Centrifugation Duration | 12 minutes | 12 minutes |
| Process of concentration and plasma Collection | Aspiration of platelet rich plasma and platelet poor plasma through a swabable Luer valve | Aspiration of platelet rich plasma and platelet poor plasma through a swabable Luer valve |
| Capacity | 60 mL | 60 mL |
Arteriocyte Medical Systems, Inc.
Traditional 510(k) Application
Page 2 of 3
{2}
## Performance Data
The following performance data were provided in support of the substantial equivalence decision:
### Bench Testing:
A study was conducted to determine whether the Precise Cell Concentration System could produce PRP from a mixture of peripheral blood and BMA collected from healthy human donors. The PRP obtained from the device was evaluated for platelet count, platelet fold, platelet yield, white blood cell count, red blood cell reduction, and platelet function. The results demonstrate substantial equivalence between the Precise Cell Concentration System and the predicate device across platelet fold, platelet yield, red blood cell reduction, p-selectin expression with or without agonist, hypotonic stress response, and pH.
A comparative study evaluated the Precise Cell Concentration System PRP against saline for bone graft handling. It assessed cohesion with PRP versus saline. Results indicate better bone graft handling with the Precise Cell Concentration System PRP than saline.
### Biocompatibility Testing:
Biocompatibility testing on the sample contacting materials of the device was conducted in accordance with ISO 10993-1, “Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing within a Risk Management Process”. The Precise Cell Concentration System is categorized as an externally communicating device with limited exposure (contact < 24 hours) with indirect blood contact. Testing included cytotoxicity, sensitization and irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility.
### Sterilization and Shelf Life:
The Precise Cell Concentration System will be sterilized using (b) (4) irradiation following a validated sterilization process in accordance with ISO 11137-1:2006/ (R) 2015 (Sterilization of health-care products — Radiation — Requirements for the development, validation and routine control of a sterilization process for medical devices). The test was conducted to evaluate the structural integrity of the product packaging following worst-case conditioning, including two (2) times sterilization and post-simulated shipping and aging. The results demonstrated that the device’s structural and functional integrity remains intact following conditioning, and the data support a 2-year shelf-life.
## Conclusion
Performance testing and a comparison of characteristics between the subject and predicate devices have demonstrated that the Precise Cell Concentration System is substantially equivalent to the predicate device in terms of operation, function, and technological characteristics.
---Arteriocyte Medical Systems, Inc.
Traditional 510(k) Application
Page 3 of 3
