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BK090057 Summary

IMMUCOR, INC.
 

6.0 510(k) SUMMARY

This summary of 51O(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant Information
Date Prepared:September 23, 2009
Applicant:Immucor, Inc.
Address:

3130 Gateway Drive
Norcross, Georgia, 30071

Establishment Registration No.:1034569
Contact Person:

Howard Yorek
Senior Director, Regulatory Affairs

Telephone:(770) 441-2051
FAX:(770) 449-0907
Device Information
Device Name:Galileo®
Common Name:Automated Blood Bank Analyzer
Classification:21 CFR§864.9175, Class II (BK040013)
Classification Name:Automated blood grouping and antibody test system
Predicate Devices
Galileo® (BK040013)

Device Description and Intended Use
The Galileo is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo automates test processing, result interpretation and data management functions. The Galileo is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping and antigen screening, and infectious disease screening such as syphilis and cytomegalovirus (CMV).

This 510(k) summary applies to the addition of Immucor Anti-A,B (Murine Monoclonal Blend) Series 1 Blood Grouping Reagent for use in ABO assays on the Galileo. The Anti-A,B reagent is used for the detection of the A and B antigens on red blood cells.

All of the Galileo 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.

Use of these assays does not require new sample handling or new instrument operational procedures. The Operator Manual has been revised to include information on the A,B assays.

The Galileo is a closed system intended for use only with the reagents specified in the Galileo Operator Manual.

Comparison to Predicate Devices

A comparison between Galileo and the predicate device is presented in the table below. The devices are compared based on technological characteristics and intended use.

Table 6.0-1: Comparison of Intended Use

Intended Use

Galileo (BK090057)

Galileo (BK040013)

Automated immunohematology analyzer for in vitro diagnostic use

X

X

Tests Performed:

ABO & Rh Typing

X

X

Antibody Screen

X

X

Antibody Identification

X

X

Crossmatch

X

X

IgG Crossmatch

X

X

Direct Antiglobulin

X

X

Red Blood Cell Phenotyping

X

X

RBC Antigen Screening

X

X

CMV Antibody Testing

X

X

Syphilis Testing

X

X

Read Test reactions by digital image analysis

X

X

Test Result Interpretation

X

X

 

Table 6.0-2: Comparison of Technical Characteristics

Technical Characteristics

Galileo (BK090057)

Galileo (BK040013)

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 confirm
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

10mL¹ and 57mL

10mL¹ 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

Centrifuge performed at a consistent rpm range and
duration

X

X

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

¹ Reagent volume in 1OmL vial may vary

Summary of Non-Clinical Tests

In-house testing was performed to evaluate equivalency of the Anti-A,B reaction results when tested on the Galileo with the Anti-A,B reaction results when tested by the reference method (manual tube). Equivalency was evaluated for both assay types that will use the reagent: Forward ABO testing and full ABO testing.

The results of the studies demonstrate that use of Immucor Anti-A,B (Murine Monoclonal Blend) Series 1 reagent on the Galileo will generate results equivalent to the established reference method. The agreement rate of the equivalency testing performed was above 99%.

Summary of Clinical Tests

Clinical testing of the ABO assays using FDA-licensed and 510(k)-cleared reagents was originally submitted and reviewed under BK040013. The results of the clinical testing supported the conclusion that the Galileo is safe and effective for the automated execution of ABO assays. The results of the clinical studies demonstrated that end users, with proper training, could use the Galileo to perform the in vitro diagnostic tests defined for Galileo and that the testing with specified reagents on the Galileo would generate results comparable to established reference methods.

In support of the current premarket notification additional Clinical testing was performed at an external facility to validate the use of Immucor Anti-A,B (Murine Monoclonal Blend) Series 1 on the Galileo in a user test site. Total data concordance was 100% between the Galileo ABORH_AB assay and the reference method manual tube testing Anti-A,B results and total data concordance was 99.6% between the Galileo FWDABO_AB assay and the reference method manual tube testing Anti-A,B results.

The non-clinical and clinical performance data demonstrates that the Galileo test results with AntiA,B (Murine Monoclonal Blend) Series 1 are substantially equivalent to manual tube reference method.