← Product Code [GKT](/productcode/GKT) · BK241097 # Rika Plasma Donation System (42000) (BK241097) _Terumo BCT, Inc. Lakewood, CO · GKT · Nov 5, 2024 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/BK241097 ## Device Facts - **Applicant:** Terumo BCT, Inc. Lakewood, CO - **Product Code:** [GKT](/productcode/GKT.md) - **Decision Date:** Nov 5, 2024 - **Decision:** SESE - **Regulation:** 21 CFR 864.9245 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The Rika Plasma Donation System is an automated blood cell separator device and single-use sterile disposable set intended for use in collecting source plasma with or without saline compensation. ## Device Story Automated blood collection system; uses centrifugal force to separate whole blood into plasma and cellular components. Input: whole blood from donor. Process: channel-based centrifugal separation; plasma collected; remaining cells and saline (if configured) returned to donor. Output: source plasma. Used in blood donation centers; operated by trained personnel. Modified saline hook component facilitates saline administration. System ensures safe and effective plasma collection via automated protocols. ## Clinical Evidence Bench testing only. Performance testing demonstrated that the Rika Plasma Donation System with the modified saline hook meets all established performance requirements and is usable by intended users. ## Technological Characteristics Automated blood cell separator; channel-based centrifugal separation principle. System includes embedded software and protocols. Modified wide saline hook. Operates as a standalone system for blood component collection. ## Regulatory 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 - Terumo BCT: Rika Plasma Donation System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **Rika Plasma Donation System** Modified Saline Hook Traditional 510(k) Submission--- **TERUMO** BLOOD AND CELL TECHNOLOGIES ## **510(K) SUMMARY** In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary is provided. {1} TERUMO BLOOD AND CELL TECHNOLOGIES # 510(k) Summary I. SUBMITTER Terumo BCT, Inc. 10811 W. Collins Avenue Lakewood, Colorado 80215 Phone: 720-480-6702 Contact Person: Ashley Davis Title: Principal Specialist, Regulatory Affairs Phone: 303-542-5494 Fax: 303-231-4756 Date Prepared: DATE II. DEVICE Trade Name of Device: Rika Plasma Donation System Common or Usual Name: Automated Blood Collection System, or Separator, Automated, Blood Cell, Diagnostic/ Automated Blood Cell Separator Classification Name: Separator, Automated, Blood Cell, Diagnostic Regulatory Number: 21 CFR 864.9245(b) Product Code: GKT III. DEVICE CHARACTERISTICS SUMMARY The Rika Plasma Donation System is an automated blood component collection system that uses centrifugal force to separate whole blood into plasma and its remaining cells. The plasma is collected, and the remaining cells and saline, if configured, are returned to the donor. IV. INDICATIONS FOR USE The Indication for Use statement for the Rika Plasma Donation System is as follows: The Rika Plasma Donation System is an automated blood cell separator device and single-use sterile disposable set intended for use in collecting source plasma with or without saline compensation. Terumo BCT, Inc. 10811 West Collins Ave. Lakewood, Colorado 80215-4440 USA USA Phone: 1.877.339.4228 Phone: +1.303.231.4357 Fax: +1.303.542.5215 Terumo BCT Europe N.V. Europe, Middle East and Africa Ikaroslaan 41 1930 Zaventem Belgium Phone: +32.2.715.05.90 Fax: +32.2.721.07.70 Terumo BCT (Asia Pacific) Ltd. Room 3903-3903A, 39/F ACE Tower, Windsor House 311 Gloucester Road Causeway Bay, Hong Kong Phone: +852.2283.0700 Fax: +852.2576.1311 Terumo BCT Latin America S.A. La Pampa 1517 – 12th Floor C1428DZE Buenos Aires Argentina Phone: +54.11.5530.5200 Fax: +54.11.5530.5201 Terumo BCT Japan, Inc. 20-14, 3-chrome Higashi Gotanda, Shinagawa-ku Tokyo 141-0022 Japan Phone: +81.3.6743.7890 Fax: +81.3.6743.9800 UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM {2} **TERUMO**BLOOD AND CELL TECHNOLOGIES ## V. TECHNOLOGICAL COMPARISON Provided in **Table 1** is a high-level comparison of the Rika Plasma Donation System with modified saline hook to the predicate device. | Category | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | **Device Name** | **Rika Plasma Donation System** | **Terumo BCT: Rika Plasma Donation System** | N/A | | **Classification Name** | Automated blood cell separator | Automated blood cell separator | Same | | **Regulatory Number** | 21 CFR Part 864.9245 | 21 CFR Part 864.9245 | Same | | **Product Code** | GKT | GKT | Same | | **Class** | II | II | Same | | **Indication for Use** | Collection of Source Plasma | Collection of Source Plasma | Similar | | **Fundamental Scientific Technology** | Channel based centrifugal separation | Channel based centrifugal separation | Similar | | **Software** | Embedded + Protocol | Embedded + Protocol | Same | | **Saline Hook** | Modified Wide Hook | Wide Hook | Similar | ## VI. PERFORMANCE DATA The following types of data were provided in support of the substantial equivalence determination. Each type of data is further expanded upon in the sections below. - Performance Testing ### A. Performance Testing The Rika Plasma Donation System with the modified saline hook was tested against its performance requirements through demonstration and direct testing. The testing showed that the Rika Plasma Donation System performed according to its performance requirements and is usable by the intended users. ## VII. CONCLUSIONS Based on the results of the non-clinical tests performed on the Rika Plasma Donation System with the modified saline hook, it is as safe and effective as the legally marketed predicate device. The information provided in the 510(k) demonstrates that the Rika Plasma Donation System is substantially equivalent to the identified predicate and reference devices. UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM --- **Source:** [https://fda.innolitics.com/device/BK241097](https://fda.innolitics.com/device/BK241097) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com