← Product Code [KSZ](/productcode/KSZ) · BK210604 # Complement Control Cells (BK210604) _Immucor, Inc. Norcross, GA · KSZ · Jan 8, 2025 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/BK210604 ## Device Facts - **Applicant:** Immucor, Inc. Norcross, GA - **Product Code:** [KSZ](/productcode/KSZ.md) - **Decision Date:** Jan 8, 2025 - **Decision:** SESE - **Regulation:** 21 CFR 864.9175 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use Complement Control Cells are intended for use in confirming reactivity of the anti-C3 component of Anti-Human Globulin. ## Device Story Complement Control Cells are red blood cells coated with C3b (C3c/C3d) human complement via the Fruitstone method; suspended in buffered preservative solution (adenosine, adenine, chloramphenicol, neomycin sulfate, gentamycin sulfate). Used as positive run control in blood banking to verify anti-C3 reactivity of Anti-Human Globulin reagents. Operates in manual or automated laboratory workflows (e.g., Galileo NEO/ECHO systems). Provides quality assurance for C3d DAT assays; ensures reagent performance; supports accurate clinical diagnostic testing for blood compatibility. ## Clinical Evidence Bench testing only. Performance verified using Complement Control Cells as positive run control for Automated C3d Plate in C3d DAT assays on Galileo NEO (v2.0)/NEO Iris and Galileo Echo (v2.0)/ECHO Lumena. 418 test runs on NEO and 366 test runs on ECHO were performed; 0 failures related to control cell performance. ## Technological Characteristics Red blood cells coated with C3b (C3c/C3d) via cold low-ionic-strength (Fruitstone) procedure. Concentration 2-4% in buffered preservative solution (adenosine, adenine, chloramphenicol, neomycin sulfate, gentamycin sulfate). Form factor: 3 mL in 20x60 mm glass vial with dropper assembly. Shelf life 67 days at 1-10 °C. Manual or automated use. ## Regulatory Identification An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens. ## Predicate Devices - Complement Control Cells (Pre-Amendment Device Component of Gamma Biologicals, Inc.'s RQC Kit) ## 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} Traditional 510(k) Premarket Notification ## 7.0 510(k) Summary ### Date Prepared June 4, 2021 ### 510(k) Owner/Manufacturer Immucor, Inc. 3130 Gateway Drive Norcross, Georgia 30071 Establishment Registration Number: 1034569 ### Contact Information Name of Contact: Steven Appel Phone Number: 770-440-2051 Fax Number: 770-242-8930 ### Device Name | Trade/Device Name: | Complement Control Cells | | --- | --- | | Common Name: | Complement-Coated Control Cells | | Classification Name: | Quality control kits for blood banking reagents | | Unique Device Identifier (UDI): | 10888234000914 | ### Device Class | Regulatory Class: | II | | --- | --- | | Product Code: | KSF | | Regulation Number: | 21CFR§864.9650 | | Classification Advisory Committee: | Hematology | | Review Advisory Committee: | Hematology | ### Predicate Device Information | Trade/Device Name: | Complement Control Cells | | --- | --- | | Clearance: | Pre-Amendment Device Component of Gamma Biologicals, Inc.'s RQC Kit; reagent quality control for blood banking reagents | ### Device Description Complement Control Cells is a blood bank quality control reagent used to verify the anti-C3 reactivity of Anti-Human Globulin reagents. Red blood cells are coated with the C3b (C3c/C3d) component of human complement in plasma using a cold-low-ionic-strength procedure (Fruitstone method). The C3b-coated red blood cells are suspended to a concentration of 2-4% in a buffered preservative solution containing adenosine and adenine to retard hemolysis and/or loss of reactivity during the dating period. Chloramphenicol (0.25 mg/mL), neomycin sulfate (0.1 mg/mL), and gentamycin sulfate (0.05 mg/mL) are added as preservatives. The reagent is filled into a glass vial with attached dropper assembly. For *in vitro* diagnostic use only. Modification to Complement Control Cells Addition of Automated Use Page 60 of 79 {1} Traditional 510(k) Premarket Notification IMMUCOR ## Intended Use Complement Control Cells are intended for use in confirming reactivity of the anti-C3 component of Anti-Human Globulin. ## Technological Comparison to Predicate Device Below is a comparison of the technological characteristics of modified Complement Control Cells compared to the predicate Complement Control Cells. | Characteristic | Predicate | Modified Device | | --- | --- | --- | | Trade/Device Name | Complement Control Cells (Pre-Amendment Device) | Identical | | Product Code | KSF | Identical | | Regulation Number | 21CFR§864.9650 | Identical | | Intended Use Statement | Complement Control Cells are intended for use in confirming reactivity of the anti-C3 component of Anti-Human Globulin. | Identical | | Method of Manufacturing | Prepared from whole blood using a cold low-ionic-strength procedure (Fruitstone method) | Identical | | Red Blood Cell Concentration | 2-4% | Identical | | Suspending Solution | Buffered preservative solution containing adenosine and adenine to retard hemolysis and/or loss of reactivity during the dating period. Chloramphenicol (0.25 mg/ml), neomycin sulfate (0.1 mg/ml), and gentamycin sulfate (0.05 mg/ml) are added as preservatives | Identical | | Fill Volume | 3 mL | Identical | | Shelf Life | 67 days, stored at 1-10 °C | Identical | | Container Closure | 20x60 mm glass vial with dropper assembly | Identical | | Test Method(s) | Manual | Manual Adding use in automated assays to indications for use | ## Non-clinical Performance Complement Control Cells were used as the positive run control for verification performance studies of the Automated C3d Plate in C3d DAT assays on the Galileo NEO (v2.0)/NEO Iris and Galileo Echo (v.20)/ECHO Lumena. 418 test runs were performed on the NEO's and 366 test runs were performed on the ECHO's. No test runs failed related to performance of the Complement Control Cells. ## Basis for Claim of Substantial Equivalence The successful performance testing demonstrates the safety and efficacy of the modified Complement Control Cells when used for the defined indications for use. Modification to Complement Control Cells Addition of Automated Use Page 61 of 79 --- **Source:** [https://fda.innolitics.com/device/BK210604](https://fda.innolitics.com/device/BK210604) **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. 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