BK210601 · Immucor, Inc. Norcross, GA · KSZ · Jan 8, 2025 · Hematology
Device Facts
Record ID
BK210601
Device Name
Echo Lumena
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
Echo Lumena: The Echo Lumena is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Echo Lumena automates test processing, result interpretation, and data management functions. The Echo Lumena is designed to automate standard immunohematology assays using a micro-well strip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping. The Echo Lumena is a closed system intended for use only with the reagents described in the Echo Lumena Operator Manual, Regional Attachment – North America- Echo Lumena Assay Reagents and Cutoffs. Galileo Echo: The Galileo Echo is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo Echo automates test processing, result interpretation and data management functions. The Galileo Echo is designed to automate standard immunohematology assays using a micro-well strip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing and red blood cell phenotyping. The Galileo Echo is a closed system intended for use only with the reagents described in the Galileo Echo Operator Manual, Regional Attachment – North America- Galileo Echo Assay Reagents and Cutoffs.
Device Story
Automated blood bank analyzers (Echo Lumena/Galileo Echo) perform immunohematology assays; utilize hemagglutination and solid phase red cell adherence (SPRCA) methods. Robotic system moves micro-well strips, reagents, and blood samples through incubation, washing, centrifugation, and reading stations. CCD camera captures micro-well images; software performs multi-feature image analysis to calculate reaction values; system assigns results based on predefined criteria. Used in clinical laboratories; operated by trained personnel. Provides automated result interpretation and data management; facilitates walk-away testing. Enhances laboratory efficiency and standardization of blood bank testing.
Clinical Evidence
Method comparison study conducted at two external sites and one internal site. Compared Automated C3d DAT assay on subject devices against a comparator method. Total sample set included 1,143 samples (including 86 contrived positive samples). Initial PPA 95.17% (90.16% lower CI), NPA 99.32% (98.73% lower CI). Resolved PPA 100% (97.70% lower CI), NPA 99.33% (98.74% lower CI).
Technological Characteristics
Microprocessor-controlled robotic analyzer; micro-well strip-based platform. Sensing via CCD camera-based digital image analysis. Performs hemagglutination and SPRCA. Closed system; requires specific Immucor reagents. Windows 10 OS. Connectivity to LIS. Automated incubation, washing, and centrifugation.
Indications for Use
Indicated for automated in vitro diagnostic immunohematology testing of human blood, including ABO/Rh typing, IgG antibody detection/identification, compatibility testing, red blood cell phenotyping, and C3d Direct Antiglobulin Testing (DAT).
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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Traditional 510(k) Premarket Notification
IMMUCOR
## 7.0 510(k) Summary
### Date Prepared
June 4, 2021
### 510(k) Owner
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: | Echo Lumena® | Galileo Echo® |
| --- | --- | --- |
| Common Name: | Automated Blood Bank Analyzer | Automated Blood Bank Analyzer |
| Classification Name: | Automated blood grouping and antibody test system | Automated blood grouping and antibody test system |
| Unique Device Identifier (UDI): | 10888234002338 | 10888234001584 |
### Device Class
| Trade/Device Name: | Echo Lumena® | Galileo Echo® |
| --- | --- | --- |
| Regulatory Class: | II | II |
| Product Code: | KSZ | KSZ |
| Regulation Number: | 21CFR§864.9175 | 21CFR§864.9175 |
| Classification Advisory Committee: | Hematology | Hematology |
| Review Advisory Committee: | Hematology | Hematology |
### Predicate Device Information
| Trade/Device Name: | Echo Lumena® | Galileo Echo® |
| --- | --- | --- |
| Clearance: | BK200483 | BK200483 |
| Date Cleared: | June 22, 2020 | June 22, 2020 |
### Device Description
Galileo Echo (v.2.0) is an upgrade of the Galileo Echo to bring that instrument up to the design and performance specifications of the Echo Lumena by replacement of camera and software components; both instruments are technologically and functionally identical.
The Galileo Echo (v.2.0) and Echo Lumena (hereafter "Echo" will refer to either instrument) are designed to automate standard immunohematology assays and to operate as walk-away systems, meaning you can leave the Echo to operate independently for periods of time. Several unified principles have been integrated into the Echo system to support and simplify the system's overall operation.
The Echo uses two (2) basic methods of blood testing, namely hemagglutination and solid phase red cell adherence (SPRCA). Hemagglutination is used for red blood cell typing assays which includes ABO and Rh(D) typing and red blood cell phenotyping. Solid phase is used for antibody detection and identification assays, compatibility testing and weak D.
The Echo is a closed system and can only be used with specified Immucor products. The Echo is a robotic instrument programmed to move micro-well strips, liquid reagent fluids, and blood
Traditional 510(k) Premarket Notification
Modification to Echo Lumena and Galileo Echo by Addition of Automated C3d DAT Assay
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IMMUCOR
sample fluids to different processing areas for a given assay in the correct sequence, such as the incubator, the micro-well washing station, the centrifuge, and the reader.
The Echo micro-well reader uses a CCD camera to capture an image of the micro-well. The Echo software calculates a reaction value for each well based on a multi-feature image analysis. The Echo then assigns a result and interpretation to the well based on predefined criteria associated with the calculated reaction value. Some assay protocols require multiple test wells for a given blood sample interpretation, such as ABO and Rh (D) typing.
The Echo uses software to drive its mechanics and data processing. The operator uses hardware in combination with the software to operate and maintain the Echo.
## Intended Use
The intended use of the modified devices, as described in the labeling, has not changed as a result of the modifications.
### Echo Lumena:
The Echo Lumena is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Echo Lumena automates test processing, result interpretation, and data management functions. The Echo Lumena is designed to automate standard immunohematology assays using a micro-well strip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping. The Echo Lumena is a closed system intended for use only with the reagents described in the Echo Lumena Operator Manual, Regional Attachment – North America- Echo Lumena Assay Reagents and Cutoffs.
### Galileo Echo:
The Galileo Echo is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo Echo automates test processing, result interpretation and data management functions. The Galileo Echo is designed to automate standard immunohematology assays using a micro-well strip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing and red blood cell phenotyping.
The Galileo Echo is a closed system intended for use only with the reagents described in the Galileo Echo Operator Manual, Regional Attachment – North America- Galileo Echo Assay Reagents and Cutoffs.
## Technological Comparison to Predicate Device
Below is a summary of the technological characteristics of modified Echo Lumena and Galileo Echo (proposed devices) compared to the predicate devices (BK200483).
| Properties/Features/ Characteristics | Predicates (BK200483) | Modified Echo Lumena and Galileo Echo | Comparison |
| --- | --- | --- | --- |
| Common Name | Automated Blood Bank Analyzer | Automated Blood Bank Analyzer | Identical |
| Classification | Class II | Class II | Identical |
| Regulation | 21 CFR 864.9175 | 21 CFR 864.9175 | Identical |
| Intended Use | Automated immunohematology analyzer for in vitro diagnostic use | Automated immunohematology analyzer for in vitro diagnostic use | Identical |
Traditional 510(k) Premarket Notification
Modification to Echo Lumena and Galileo Echo by Addition of Automated C3d DAT Assay
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IMMUCOR
| Properties/Features/Characteristics | Predicates (BK200483) | Modified Echo Lumena and Galileo Echo | Comparison |
| --- | --- | --- | --- |
| Indications for Use | Microprocessor controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. Automates test processing, result interpretation, and data management functions. Designed to automate standard immunohematology assays using a micro-well strip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping. | Microprocessor controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. Automates test processing, result interpretation, and data management functions. Designed to automate standard immunohematology assays using a micro-well strip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping. | Identical |
| Tests Performed | ABO & RH Typing Antibody Screen Antibody Identification IgG Crossmatch Direct Antiglobulin Antigen Typing | ABO & RH Typing Antibody Screen Antibody Identification IgG Crossmatch Direct Antiglobulin Antigen Typing | Identical |
| Test Reactions Reading | Digital Image Analysis | Digital Image Analysis | Identical |
| User Interface | By Computer Workstation | By Computer Workstation | Identical |
| System Security requires user passwords for access | Yes | Yes | Identical |
| Testing performed on Plasma | Yes | Yes | Identical |
| Testing performed on serum | Yes | Yes | Identical |
| Barcode read on reagent and samples to confirm presence and location on the instrument | Yes | Yes | Identical |
| Barcode read of reagent lot number and expiration date | Yes | Yes | Identical |
| Manual entry of sample or reagent barcode requiring double blind entry | Yes | Yes | Identical |
| Acceptable reagent vial size | 10 mL | 10 mL | Identical |
| Sample and reagent volume verification at aspiration | Yes | Yes | Identical |
| Programmed to track volume or usage of each reagent vial or plate | Yes | Yes | Identical |
| Prepares sample red cell suspension | Yes | Yes | Identical |
| Multiple vials of same reagent can be loaded on instrument. When empty instrument switches to second vial | Yes | Yes | Identical |
| Maintains Reagent Red Cell suspensions by agitation | Yes | Yes | Identical |
| Walk away testing capability | Yes | Yes | Identical |
| Instrument will discontinue operation if liquid waste is full | Yes | Yes | Identical |
| Incubation duration and temperature are monitored | Yes | Yes | Identical |
Traditional 510(k) Premarket Notification
Modification to Echo Lumena and Galileo Echo by Addition of Automated C3d DAT Assay
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| Properties/Features/ Characteristics | Predicates (BK200483) | Modified Echo Lumena and Galileo Echo | Comparison |
| --- | --- | --- | --- |
| Centrifuge performs at a consistent rpm range and duration | Yes | Yes | Identical |
| Can be interfaced to laboratory information systems | Yes | Yes | Identical |
| Camera Model/ module | Lumenera Camera | Lumenera Camera | Identical |
| Software Operating System | Microsoft Windows 10 | Microsoft Windows 10 | Identical |
| Algorithm interpretation and thresholds | Interpretation by camera imaging | Interpretation by camera imaging | Identical |
| Automated C3d DAT Assay | No | Yes | New |
### Clinical Performance
Method comparison studies were performed externally at two sites and internally at Immucor, Inc. Specimens were tested with the Automated C3d DAT assay on Galileo Echo/Echo Lumena and the comparator method. Samples with initial equivocal results were retest and the results used for calculations. Test results were evaluated for agreement with the comparator method. Results are summarized in the following tables:
Note: Agreement between methods does not indicate which method is correct.
| Initial C3d DAT | Comparator | | Agreement | | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| Galileo Echo^{#} & Echo Lumena | Positive | 99* | 7 | Positive % Agreement | 95.17% |
| | | | | PPA (95% Lower 1-sided CI) | 90.16% |
| | Negative | 5 | 1,032 | Negative % Agreement | 99.32% |
| | | | | NPA (95% Lower 1-sided CI) | 98.73% |
$^{#}$ Galileo Echo software version 2.1. Positive samples include 86 C3d-positive contrived samples.
* One contrived sample tested repeat equivocal and was removed from PPA calculation.
| Resolved C3d DAT | Comparator | | Agreement | | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| Galileo Echo^{#} & Echo Lumena | Positive | 99 | 7 | Positive % Agreement | 100% |
| | | | | PPA (95% Lower 1-sided CI) | 97.70% |
| | Negative | 0* | 1,035 | Negative % Agreement | 99.33% |
| | | | | NPA (95% Lower 1-sided CI) | 98.74% |
$^{#}$ Galileo Echo software version 2.1.
* Excludes 3 samples reacting 1+ or weaker with the comparator reagent per limitation in Operator Manuals.
### Basis for Claim of Substantial Equivalence
This Traditional 510(k) is submitted to modify legally marketed devices (predicates). Immucor, Inc. is the holder of the 510(k)s for the predicate devices. The Indications for Use of the proposed devices are unchanged from the legally marketed devices (predicates). The intended use of the modified devices, as described in the labeling, has not changed as a result of the modifications. Finally, fundamental scientific technology of the proposed devices is unchanged from the legally marketed devices (predicates). There are no significant differences between the modified
Traditional 510(k) Premarket Notification
Modification to Echo Lumena and Galileo Echo by Addition of Automated C3d DAT Assay
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IMMUCOR
instruments and the predicates as relates to Intended Use or Principle of Operation. With the exception of the addition of the automated C3d DAT Assay, the predicate and modified devices are identical.
The modified Echo Lumena and Galileo Echo instruments are as safe and effective as the currently marketed predicates under BK200483.
Traditional 510(k) Premarket Notification
Modification to Echo Lumena and Galileo Echo by Addition of Automated C3d DAT Assay
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