6.0 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR§807.92.
6.1 Applicant Information
|Date Prepared:||May 27,2010|
|Address:||3130 Gateway Drive|
|Norcross, Georgia 30071|
|Establishment Registration Number:||1034569|
|Contact Person:||Howard Yore|
|Senior Director, Regulatory Affairs|
6.2 Device Information
|Trade Name:||Galileo Neo|
|Model Number:||Product Code 0064599|
|Software Version:||Version 1.5.8(2)/DMS 1.40 SP5|
|Common Name:||Automated Blood Bank System|
|Classification Name:||Automated blood grouping and antibody test system|
|(21CFR 864.9175, Product Code KSZ)|
6.3 Predicate Device
Galileo® Automated Blood Bank System Capture-CMV: BK050050, cleared November 14, 2005
Galileo® Automated Blood Bank System: BK080070, cleared February 5, 2009 (last cleared 510(k) submission)
6.4 Device Description
The NEO is the next generation instrument in lmmucor's automated immunohematology product line. It is an updated version of its predicate device, the Galileo. The NEO is based on the Galileo platform and is a microprocessor-controlled instrument designed to fully automate immunohematological in vitro diagnostic testing of human blood. The NEO automates test processing, result interpretation and data management functions. The NEO is designed to automate standard immunohematology assays using a microplate-based platform. Assays include, but are not limited to, ABO grouping and Rh (D) typing, detection/identification of lgG red blood cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening such as cytomegalovirus (CMV).
The NEO is a closed system intended for use only with the reagents specified in Appendix 1 of the Galileo NEO Operator Manual.
The NEO is a robotic instrument programmed to move microplates, liquid reagent fluids, and blood sample fluids to different bays and processing areas for a given assay in the correct sequence, such as incubator bays, the microplate washing station, the centrifuge, and the reader. The NEO plate reader uses CCD cameras to capture an image of the microplate from underneath. The NEO software calculates a reaction value for each well based on a multi-feature image analysis. The NEO then assigns a result and interpretation to the wells 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 NEO uses software to drive its mechanics and data processing. The operator uses hardware in combination with the software to operate and maintain the NEO.
All of NEO's functions are fully automated, including: sample and reagent handling, pipetting, incubation, washing, shaking, centrifugation, reading and interpretation of results. Automated process controls and error detection mechanisms significantly reduce or eliminate opportunities for user error and invalidate suspect results.
6.5 Intended Use
The Galileo Neo (NEO) is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO automates test processing, result interpretation and data management functions. The NEO is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of lgG red blood cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening, and infectious disease screening, such as cytomegalovirus (CMV). The antigen screening assays provide guidelines for the user to select antisera or dilute commercial blood grouping reagents as a mechanism to prescreen for antigen negative blood units that can then be subjected to confirmation using a licensed method.
The NEO is intended for use only with the reagents described in Appendix 1 for Galileo NEO Operator Manual.
6.6 Comparison to Predicate Device
A comparison between NEO and the predicate device Galileo is presented in the Tables 6.6-1 and 6.6-2 below. The devices are compared based on technological characteristics and intended use.
Both Galileo and NEO are designed to automate standard immunohematology assays using a microplate-based platform. Assays are the same for both to include, but are not limited to, ABO grouping and Rh (D) typing, detection/identification of lgG red blood cell antibodies, crossmatching, phenotyping, antigen screening and cytomegalovirus antibody (CMV) screening. Both the Galileo and NEO automate test processing, result interpretation and data management functions. Both Galileo and NEO are closed systems intended for use only with the reagents specified in their respective operator manuals. The intended use of the NEO and the Galileo are the same.
Table 6.6-1: Intended Use Comparison
|Automated immunohematology system for in vitro diagnostic use|
|ABO & Rh Typing|
|Direct Antiglobulin Test|
|CMV Antibody Testing|
|Syphilis Testing (Note: Capture-S assay was discontinued January 2010)|
|Read Test reactions by digital image analysis|
|Test Result Interpretation|
* NEO intended use previously reviewed by FDA and cleared under BK100001
NEO has the same technological characteristics as Galileo, as it is built upon an updated Galileo platform and shares many hardware and software components. The specific similarities and differences in the hardware and software are described in detail in BK100001; which FDA has previously reviewed with the determination that the technological characteristics the NEO and Galileo are substantially equivalent.
Table 6.6-2: Technical Characteristics Comparison (all technical characteristics of the NEO instrument have been previously reviewed under BK100001)
|User interface using computer workstation||X||X|
|System security requires user passwords for access||X||X|
|Testing performed on plasma||X||X|
|Testing performed on serum||X||X|
|Barcode read on reagent and samples to on firm presence and location on the instrument||X||X|
|Barcode read of reagent lot number and expiration date||X||X|
|Manual entry of sample or reagent barcode requiring double blind entry||X||X|
|Acceptable reagent vial size||10mL* and 57mL||10mL* and 57mL|
|Sample and reagent volume verification at aspiration||X||X|
|Programmed to track volume or usage of each reagent vial or plate||X||X|
|Prepares sample red cell suspension||X||X|
|Multiple vials of same reagent can be loaded on instrument. When empty instrument switches to second vial.||X||X|
|Maintains red cell suspensions by agitation||X||X|
|Walk away testing capability||X||X|
|Instrument will discontinue operation if liquid waste is full||X||X|
|Incubation duration and temperature are monitored||X||X|
|Plate washed with controlled volume and flow rate||X||X|
|Washer dispense / aspiration checks||Semi-automated||Fully Automated|
|Centrifuge performed at specified rpm values and durations||X||X|
|Pipettor check maintenance function||Semi-automated||Fully-automated|
|Error message for dispense verification discrepancy prior to result reading||X||X|
|Blood type test results interpreted against standard industry interpretation tables||X||X|
|Can be interfaced to laboratory information systems||X||X|
* Reagent volume in 10mL vial may vary
6.7 Nonclinical Performance Testing
Non-clinical studies were conducted in-house at Immucor to verify that the NEO performs as expected prior to performing external clinical testing. A total of 547 samples were tested with the CMV assay, including 417 donor samples and 130 patient samples. The samples were acquired from external collection facilities and were all drawn in EDTA anticoagulant. Testing was performed using two lots each of Capture-CMV Microplates and Capture-CMV Indicator Red Cells. The study demonstrated a 99.1 %-100% concordance between results of CMV screening assays performed on the predicate Galileo and on the NEO.
6.8 Clinical Performance Testing
Clinical studies were conducted to confirm non-clinical in-house test results obtained with NEO instrument perform as expected when placed in end user facilities. The objective of these studies was to demonstrate that:
1) End users, with proper training, could use the NEO to perform the Capture-CMV Assay on the NEO.
2) The testing with Capture-CMV reagents on the NEO would generate results comparable to the previously cleared Galileo instrument.
The CMV assay was used to test for CMV antibodies (lgG and lgM) in 630 samples. This testing was conducted at three test sites. The number of samples tested and test runs performed are as follows:
Table 6.8-1: Distribution of Samples between Testing Sites Used for Clinical Performance Testing
Transfusion Service Blood Collection Center Immucor Total Donors Tested 0 300* 110 410 Patients Tested 100 0 120 220 Serum samples 0 100 60 160 Plasma samples 100 200* 170 470 Number of runs 3 10 6 19
* 13 of these donors were Autologous donors
Of the 220 total patient samples tested, 160 were known CMV antibody-positive samples; nine of these positive patient samples represented visually weak positive reactions (weakly-reactive samples).
The NEO results were compared to the facility's Galileo instrument and the discrepancies were investigated. Total concordance is 98.6%. There is an agreement rate of 100% (PPA) and 96.5% (NPA) between the NEO CMV results and Galileo CMV results.
Table 6.8-2: Statistical Comparison between NEO and Galileo Clinical Performance Testing Results
|CMV Statistic||Point Estimate||95% One-Sided Lower Confidence Bound|
|Positive Percent Agreement||100%||99.4%|
|Negative Percent Agreement||96.5%||94.0%|
Total data concordance was 98.6% between the NEO CMV assay and the reference method Galileo CMV assay. There were no invalid results generated by the NEO or Galileo instruments. There were no false negative results generated by the NEO instrument. The NEO is as effective as the Galileo instrument for detecting CMV antibodies and therefore is also substantially equivalent to Galileo instrument in this regard.
6.9 Statement of Substantial Equivalence
Review of the intended use, technical characteristics, and the results of clinical and non-clinical performance testing demonstrates that the Galileo Neo (NEO) is as safe, as effective, and performs as well as or better than the predicate device (Galileo) when used to screen donor and patient blood samples for the presence of antibodies to cytomegalovirus (CMV).