BK210604 · Immucor, Inc. Norcross, GA · KSZ · Jan 8, 2025 · Hematology
Device Facts
Record ID
BK210604
Device Name
Complement Control Cells
Applicant
Immucor, Inc. Norcross, GA
Product Code
KSZ · Hematology
Decision Date
Jan 8, 2025
Decision
SESE
Regulation
21 CFR 864.9175
Device Class
Class 2
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.
Indications for Use
Indicated for use as a quality control reagent in blood banking to confirm the reactivity of the anti-C3 component of Anti-Human Globulin reagents in both manual and automated assays.
Regulatory Classification
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)
{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
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{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
