BK230971 · Bio-Rad Medical Diagnostics GmbH Redmond, WA · KSZ · Aug 9, 2023 · Hematology
Device Facts
Record ID
BK230971
Device Name
IH-500
Applicant
Bio-Rad Medical Diagnostics GmbH Redmond, WA
Product Code
KSZ · Hematology
Decision Date
Aug 9, 2023
Decision
SESE
Regulation
21 CFR 864.9175
Device Class
Class 2
Indications for Use
The IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens. The IH-500 automates pipetting of samples and reagents, incubation and centrifugation, and provides reaction grading / interpretation based on results from gel card images. Analysis includes ABO, Rh(D) (including weak D and partial D testing), Rh Phenotype and Kell blood grouping, antibody screening and identification of red blood cell alloantibodies, crossmatch, auto control, direct antiglobulin testing and antibody titration testing. In the USA, IH-500 is “Rx only”. The IH-500 may only be operated by trained personnel and is not intended for use in a direct patient environment. Use of the IH-500 is only permitted in conjunction with the corresponding software or in a configuration authorized by Bio-Rad. Use of IH-500 is only permitted with gel cards and reagents from the IH-System as authorized by Bio-Rad. The use of any material not specified in the U.S. User Manual (e.g. non-authorized substances) is forbidden.
Device Story
Automated blood bank analyzer; processes human serum, plasma, and red blood cell samples. System automates pipetting, incubation, centrifugation, and image acquisition of gel cards. Integrated IH-Com software analyzes gel card images to determine reaction strength and interpret results based on predefined rules. Operated by trained personnel in clinical laboratories; connects to Laboratory Information System (LIS) for data management. Provides automated blood grouping and antibody testing; improves workflow efficiency and standardization of interpretation compared to manual methods.
Clinical Evidence
Bench testing only. Verification and validation activities were performed to confirm the system meets software requirements for version 3.1. No clinical data provided.
Technological Characteristics
Automated immunohematology analyzer; includes pipetting arm, 6-axis robotic card transport, two independent 37°C incubators, and two centrifuges. Uses gel card technology for serological reactions. Features integrated touch screen, barcode reader, and LIS connectivity. Software-based image analysis and rule-based interpretation. System uses specific wash and decontamination solutions (NaOH, Microcide).
Indications for Use
Indicated for in vitro serological analysis of human blood specimens for blood grouping (ABO, Rh(D), Rh phenotype, Kell) and antibody detection (screening, identification, crossmatch, auto control, DAT, titration). For use by trained personnel in clinical laboratory settings; not for direct patient environment.
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.
{0}
Bio-Rad Medical Diagnostics GmbH
IH-500 v3.1
Automated blood grouping and antibody test system
Special 510(k)
## SECTION 6 – 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance to requirements of SMDA 1990 and 21 CFR §807.92.
**1. Company:** Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1
63303 Dreieich, Germany
Contact: Dr. Marc Gorzellik
Phone: +49 (0) 6103 3130-528
Fax: +49 (0) 6103 3130-646
Date Summary Prepared: July 05, 2023
# **2. Device Name:**
Device Trade Name: IH-500
Version: 3.1
Common Name: Automated Blood Bank Analyzer
Classification Name: Automated System for Blood Grouping and Antibody Test System
Product Code: KSZ
Regulation Number: 21 CFR 864.9175
Regulatory Class: Class II
# **3. Identification of Legally Marketed Device (Predicate Device):**
Device Trade Name: IH-500
Version: 3.0
Common Name: Automated Blood Bank Analyzer
Classification Name: Automated System for Blood Grouping and Antibody Test System
510(k) Number: BK210625
Product Code: KSZ
Regulation Number: 21 CFR 864.9175
Regulatory Class: Class II
Clearance Letter: February 24, 2022
July 2023
CONFIDENTIAL
1 of
{1}
Bio-Rad Medical Diagnostics GmbH
IH-500 v3.1
Automated blood grouping and antibody test system
Special 510(k)
#### 4. Description of the Device:
The IH-500 automated process includes sample identification, automated recording of reagents (lot numbers, expiration dates), sample dilutions, reagent addition and mixing, incubation and centrifugation, image acquisition and analysis. Through data management software (IH-Com), it is possible to compile and transmit information to an existing Laboratory Information System (LIS).
The IH-500 Analyzer is used for the following tests:
- ABO+RhD Blood Grouping, including Reverse Grouping and weak D testing
- Rh phenotyping (C, c, E, e) and Kell blood grouping (K)
- Antibody screening and identification
- Direct Antiglobulin Testing (DAT)
- AHG Crossmatch
- Antibody Titration Testing
The IH-500 analyzer system consists of the following primary components:
- IH-500 analyzer
- Integrated touch screen monitor with keyboard
- IH-Com software
- Computer
- Hand-held barcode reader
- Printer
- Smartcard reader for user identification
#### 5. Intended Use:
The IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens. The IH-500 automates pipetting of samples and reagents, incubation and centrifugation, and provides reaction grading / interpretation based on results from gel card images. Analysis includes ABO, Rh(D) (including weak D and partial D testing), Rh Phenotype and Kell blood grouping, antibody screening and identification of red blood cell alloantibodies, crossmatch, auto control, direct antiglobulin testing and antibody titration testing.
July 2023
CONFIDENTIAL
2 of
{2}
Bio-Rad Medical Diagnostics GmbH
IH-500 v3.1
Automated blood grouping and antibody test system^{}[] Special 510(k)
In the USA, IH-500 is “Rx only”. The IH-500 may only be operated by trained personnel and is not intended for use in a direct patient environment. Use of the IH-500 is only permitted in conjunction with the corresponding software or in a configuration authorized by Bio-Rad. Use of IH-500 is only permitted with gel cards and reagents from the IH-System as authorized by Bio-Rad. The use of any material not specified in the U.S. User Manual (e.g. non-authorized substances) is forbidden.
## 6. Comparison to Predicate Device
| Parameter | Predicate Device IH-500 v3.0 | Subject Device IH-500 v3.1 |
| --- | --- | --- |
| Indications for Use Statement | The IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens. The IH-500 automates pipetting of samples and reagents, incubation and centrifugation, and provides reaction grading / interpretation based on results from gel card images. Analysis includes ABO, Rh(D) (including weak D and partial D testing), Rh Phenotype and Kell blood grouping, antibody screening and identification of red blood cell alloantibodies, crossmatch, auto control, direct antiglobulin testing and antibody titration testing. In the USA, IH-500 is “Rx only”. The IH-500 may only be operated by trained personnel and is not intended for use in a direct patient environment. Use of the IH-500 is only permitted in conjunction with the corresponding software or in a configuration authorized by Bio-Rad. Use of IH-500 is only permitted with gel cards and reagents from the IH-System as authorized by Bio-Rad. The use of any material not specified in the U.S. User Manual (e.g. non-authorized substances) is forbidden. | same |
| Classification | II | same |
July 2023
CONFIDENTIAL
3 of
{3}
Bio-Rad Medical Diagnostics GmbH
IH-500 v3.1
Automated blood grouping and antibody test system
Special 510(k)
| Parameter | Predicate Device IH-500 v3.0 | Subject Device IH-500 v3.1 |
| --- | --- | --- |
| Product code | KSZ | same |
| 510(k) number | BK210625 | - |
| Regulation number | 21 CFR 864.9175 | same |
| Common name | IH-500 fully automated system for immunohematology diagnostics | same |
| Software version | v3.0 | v3.1 |
| Primary components | • Analyzer • One computer • Integrated adjustable touch screen monitor with keyboard • Software with license dongle • Hand-held bar code reader • Printer • Smartcard reader for user identification | same |
| Specimen types | Plasma, serum and red blood cells | same |
| Capability to process STAT samples | True Stat function, through the multi-module concept which ensures the highest range of flexibility in sample processing | same |
| QC procedures implemented | Yes | same |
| Barcode reading | Sample identification, reagent lot #, and expiration date | same |
| Manual entry of sample IDs or reagent data | Requires double blind entry with user identification | same |
| Sample loading - random access | Yes | same |
| Reagent positions | • 34 positions for RRBCs and solution racks min 2 adaptable to the appropriate sample number to be tested | same |
| Reagent Red Blood Cell suspension | • Cooled storing area for reagents with agitating movements for each reagent vial | same |
| Sample/reagent dispensing (pipetting) unit | • One pipetting arm, with access to the loaded reagents and samples | same |
| Card transport | • 6-axis robot transport arm with | same |
July 2023
CONFIDENTIAL
4 of
{4}
Bio-Rad Medical Diagnostics GmbH
IH-500 v3.1
Automated blood grouping and antibody test system
Special 510(k)
| Parameter | Predicate Device IH-500 v3.0 | Subject Device IH-500 v3.1 |
| --- | --- | --- |
| system | gripper and presence sensor controlled; Internal camera contains the barcode reading function | |
| Incubator | Two independent temperature areas: Pipetting area: room temperature Incubation area: 37°C | same |
| Centrifuge | 2 independent centrifuges (2x12 IH-Cards) to ensure fast automated sample processing at all times | same |
| System solutions and waste containers | • Wash Solution A in concentrated form as system liquid • NaOH 0.5M as decontamination liquid • Microcide as decontamination solution for weekly maintenance • Waste solution in separate cans Waste bin for IH-Cards | same |
| Dispense verification | Through automatic distribution control function of the system | same |
| Result reading | The software analyses the reaction strength of the image in the corresponding IH-Card | same |
| Test interpretation | The system analyses the image and determines the reaction strength for each micro tube of the IH-Card. The final result interpretation is done by the IH-Com software, using predefined rules. | same |
| Reports | Daily journal Results and protocols QC reports Patient work list | same |
| Interfaces | Bidirectional with Laboratory Information System | same |
| Useful life | 5 years minimum | same |
| Tests performed | • ABO blood group and Rh (D) antigen typing • CcEeK Typing • Antibody screening • Antibody identification • AHG crossmatch | |
July 2023
CONFIDENTIAL
5 of
{5}
Bio-Rad Medical Diagnostics GmbH
IH-500 v3.1
Automated blood grouping and antibody test system
Special 510(k)
| Parameter | Predicate Device IH-500 v3.0 | Subject Device IH-500 v3.1 |
| --- | --- | --- |
| | • Direct antiglobulin test • Antibody titration testing | |
| Sample loading capacity | 50 samples 164 IH-Cards 34 reagent vials Continuous loading | same |
| Card loading capacity | 164 IH-Cards | same |
| Barcode type | • Code 39, 93, 128 • Interleaved 2 of 5 • EAN-8 • CODABAR with control character suppressed • UCC-EAN 128 with control character suppressed • ISBT 128 with specific characters • EAN-13 (equal to UPC-A 13) • 2D (GTIN-14) | same |
### 7. Conclusion
The verification and validation activities for IH-500 v3.1 have been completed and the results have been found satisfactory to confirm the system is meeting the software requirements.
Bio-Rad concludes, based on all information described in this submission that IH-500 v3.1 is safe, effective and substantially equivalent to the predicate device IH-500 v3.0.
July 2023
CONFIDENTIAL
6 of
