The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use as a control microtube. For use with the DG Gel System. For in vitro diagnostic use.
Device Story
DG Gel 8 Neutral card consists of plastic support with eight microtubes containing buffered gel; used for immunohematology testing. Input: human blood samples. Principle: gel column agglutination technique; antibodies react with red blood cells within gel matrix. Output: agglutination grade, absence of agglutination, or hemolysis. Used in clinical laboratories; operated by trained laboratory personnel. Compatible with automated instruments (Erytra Eflexis, Erytra, WADiana Compact) or manual processing (DG Spin, DG Therm, DG Reader). Output used by clinicians to determine blood compatibility, antibody presence, or titration levels. Benefits: standardized, reliable detection of red blood cell antibodies.
Clinical Evidence
Bench testing only. Performance studies demonstrated that the addition of single dilution titration tests did not negatively impact the performance of the DG Gel 8 Neutral card compared to the predicate device.
Technological Characteristics
Plastic card with 8 microtubes containing buffered gel medium. Immunohematology gel technique. Ready-to-use. Storage 2-25°C. Compatible with automated (Erytra Eflexis, Erytra, WADiana Compact) and manual (DG Spin, DG Therm, DG Reader) systems.
Indications for Use
Indicated for detection of antibodies to red blood cell antigens in human blood samples and as a control microtube. Used with DG Gel System for in vitro diagnostic testing.
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.
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Diagnostic Grifols, S.A.
510(k) Premarket Notification
DG Gel 8 Neutral
5 - 1
# **CH2.03 – 510(k) Summary**
# **Contact Details:**
Name Diagnostic Grifols S.A.
Address Passeig Fluvial, 24, Parets del Valles
Barcelona, 08150, Spain
Establishment Registration Number: 3002772505
Contact Person: Elvira Estapé Egea
Regulatory Affairs Manager
elvira.estape@grifols.com
Phone: (34) 670-922-237
Date of Summary: March 7th, 2025
# **Device Name:**
Trade Name: DG Gel 8 Neutral
Classification Name: Automated Blood Grouping and Antibody Test System
Device Class: II
Product Code: KSZ
Regulation Number: 21 CFR 864.9175
# **Legally Marketed Predicate Device:**
Trade Name: DG Gel 8 Neutral
Classification Name: Automated Blood Grouping and Antibody Test System
510(k) Number: BK220754
Device Class: II
Product Code: KSZ
Regulation Number: 21 CFR 864.9175
Clearance Letter November 1, 2022
# **Device Description:**
DG Gel 8 Neutral card consists of a plastic support with eight (8) microtubes containing gel in a buffered medium. Each microtube is made of a chamber, also known as incubation chamber, at the top of a long and narrow microtube, referred to as the column. Buffered gel solutions have been prefilled into the microtubes of the plastic card. The microtubes, without antibodies, are used in techniques where antibodies react directly with the red blood cells.
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Diagnostic Grifols, S.A.
510(k) Premarket Notification
DG Gel 8 Neutral
5 - 2
# Indications for Use:
The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use as a control microtube.
For use with the DG Gel System.
For in vitro diagnostic use.
Comparison to Predicate Device:
| Parameter | Predicate Device Diagnostic Grifols S.A. DG Gel 8 Neutral (BK220754) | Subject Device Diagnostic Grifols S.A. DG Gel 8 Neutral |
| --- | --- | --- |
| Indications for Use Statement | The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use as a control microtube. For use with the DG Gel System. For in vitro diagnostic use. | The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use as a control microtube. For use with the DG Gel System. For in vitro diagnostic use. |
| Classification | II | II |
| Product Code | KSZ | KSZ |
| Regulation number | 21 CFR 864.9175 | 21 CFR 864.9175 |
| Common name | Automated Blood Grouping and Antibody Test System | Automated Blood Grouping and Antibody Test System |
| Principle of the test | Immunohematology gel technique | Immunohematology gel technique |
| Techniques | Saline techniques: - Determination of the ABO reverse group - ABO compatibility test (immediate spin crossmatch test) - Antibody detection (at cold, room temperature and 37°C) - Antibody titration test - Use as a Control microtube Enzymatic techniques: Screening and/or identification of unexpected antibodies | Saline techniques: - Determination of the ABO reverse group - ABO compatibility test (immediate spin crossmatch test) - Antibody detection (at cold, room temperature and 37°C) - Antibody titration test (including single dilution titration test) - Use as a Control microtube Enzymatic techniques: Screening and/or identification of unexpected antibodies |
| Results | Report results as an agglutination grade, absence of agglutination or hemolysis. | Report results as an agglutination grade, absence of agglutination or hemolysis. |
| Storage conditions | 2 - 25°C | 2 - 25°C |
| Reagent preparation | Ready to use. | Ready to use. |
| Number of microtubes | 8 | 8 |
{2}
Diagnostic Grifols, S.A.
510(k) Premarket Notification
DG Gel 8 Neutral
5 - 3
| Parameter | Predicate Device Diagnostic Grifols S.A. DG Gel 8 Neutral (BK220754) | Subject Device Diagnostic Grifols S.A. DG Gel 8 Neutral |
| --- | --- | --- |
| **Instruments for automated method** | Erytra Eflexis, Erytra or WADiana Compact. | Erytra Eflexis, Erytra or WADiana Compact. |
| **Instruments for manual method** | DG Spin, DG Therm, DG Reader Net (optional) and DG Reader (optional) | DG Spin, DG Therm, DG Reader Net (optional) and DG Reader (optional) |
The differences between the DG Gel 8 Neutral card and its predicate device, the DG Gel 8 Neutral (BK220754), are related to the Antibody Titration technique. The DG Gel 8 Neutral card allows performing a single dilution or a single point within antibody titration technique, when required by the user, in comparison to the predicate device. These differences do not raise new concerns of safety and effectiveness.
#### **Performance:**
All required performance tests have been conducted with acceptable results. The performance studies have demonstrated that performance of DG Gel 8 Neutral was not negatively impacted by allowing single dilution titration tests, when required by the user.
#### **Conclusions:**
Diagnostic Grifols S.A. concludes, based on all the information submitted and discussed in this submission and in this summary that DG Gel 8 Neutral, when used for the defined indications for use, performs as well as or better than the legally marketed predicate device DG Gel 8 Neutral (BK220754).
