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BK110050 Summary

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Checkcell

Indications for Use: Checkcell is used to confirm the validity of negative antiglobulin tests.

The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.


STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Checkcell (Weak)

Indications for Use: Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests.

The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.


STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: DAT Positive Control Cell

Indications for Use: Immucor’s DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DAT Positive control cell are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments.

The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.


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:August 25, 2011
Applicant:Immucor, Inc.
Address:3130 Gateway Drive
 Norcross, Georgia 30071
Establishment Registration Number:1034569
Contact Person:Howard Yorek
 Senior Director, Regulatory Affairs
Telephone:(770) 441-2051
Fax:(770) 242-8930

6.2        Device Information

Trade Name:Checkcell®
Common Name:IgG-coated red blood cells
Classification Name:Quality control kit for blood banking reagents
(21CFR§864.9650; Product Code KSF)
Performance Standards:Performance standards have not been established for this product
Predicate Device:Checkcell
BK820019 (Cleared Date: December 15, 1982)

 

Trade Name:Checkcell (Weak)®
Common Name:IgG-coated red blood cells
Classification Name:Quality control kit for blood banking reagents
(21CFR§864.9650; Product Code KSF)
Performance Standards:Performance standards have not been established for this product
Predicate Device:Checkcell (Weak)
BK040057 (Cleared Date: October 6, 2004)

 

Trade Name:DAT Positive Control Cell®
Common Name:IgG-coated red blood cells
Classification Name:Quality control kit for blood banking reagents
(21CFR§864.9650; Product Code KSF)
Performance Standards:Performance standards have not been established for this product
Predicate Device:DAT Positive Control Cell
BK040023 (Cleared Date: April 23, 2004)

6.3        Device Description − Checkcell

Device Description and Intended Use

Immucor’s Checkcell is composed of IgG-coated red blood cells used as a control to confirm the validity of negative antiglobulin tests.

Summary and Principle of Assay Methodology

The antiglobulin (Coombs) test is used for the detection of IgG and/or complement bound to the red blood cells. The direct antiglobulin test is used to demonstrate antibodies and/or complement bound to the red blood cells in vivo, and the indirect antiglobulin test is used, after incubation of serum/plasma and red blood cells, to demonstrate antibodies and/or complement bound in vitro.

Anti-Human Globulin used in the antiglobulin test can be rendered nonreactive by unbound serum proteins. For this reason, it is essential that appropriate controls be included to ensure proper performance of the antiglobulin reagent. Checkcell, a pool of group O, D-positive red blood cells sensitized (coated) with IgG anti-D, is used as a positive control in the antiglobulin test when performed by test tube methodology.

Checkcell is used as a positive control for antiglobulin testing using test tube methodology to verify the addition and the activity of the anti-IgG component of Anti-Human Globulin (AHG). AHG that does not agglutinate properly washed red blood cells in an antiglobulin test should remain in the active state and should be capable of agglutinating Checkcell when it is added at the final quality control stage of the test. If AHG has been omitted from the test, or it has been inactivated, no agglutination of the Checkcell reagent will occur. Tests in those tubes in which Checkcell is negative must be repeated and the original results considered invalid.

A negative result obtained with Checkcell indicates that the AHG was omitted or neutralized before or during use. The most likely scenario for failure of the Checkcell to be positive is neutralization of AHG. Neutralization is usually the result of the introduction of very small amounts of human IgG to AHG either through improper handling or inadequate washing of the antiglobulin test which leads to inactivation or neutralization of the AHG anti-IgG reagent component. Such a scenario could give rise to falsely negative test results. Checkcell functions as a positive control mechanism in this scenario.

Formulation

Checkcell is a single vial of pooled group O, D-positive red blood cells that have been sensitized with  IgG anti-D. These red blood cells have been prepared as a 4-6% suspension in a buffered preservative solution containing adenosine and adenine to retard hemolysis during the dating period. Chloramphenicol (0.25 mg/mL), neomycin sulfate (0.1 mg/mL) and gentamycin sulfate (0.05 mg/mL) are added as preservatives.

Stability

Checkcell has a 67-day expiration based on the earliest date that blood is withdrawn from any donor.

6.4        Device Description − Checkcell (Weak)

Device Description and Intended Use

Immucor’s Checkcell (Weak) is composed of IgG-coated red blood cells used as a control to confirm the validity of negative antiglobulin tests.

Summary and Principle of Assay Methodology

The antiglobulin (Coombs) test is used for the detection of IgG and/or complement bound to the red blood cells. The direct antiglobulin test is used to demonstrate antibodies and/or complement bound to the red blood cells in vivo, and the indirect antiglobulin test is used, after incubation of serum/plasma and red blood cells, to demonstrate antibodies and/or complement bound in vitro.

Anti-Human Globulin used in the antiglobulin test can be rendered nonreactive by unbound serum proteins. For this reason, it is essential that appropriate controls be included to ensure proper performance of the antiglobulin reagent. Checkcell (Weak), a pool of group O, D-positive red blood cells sensitized (coated) with IgG anti-D, is used as a positive control in the antiglobulin test when performed by test tube methodology.

Checkcell (Weak) is used as a positive control for antiglobulin testing using test tube methodology to verify the addition and the activity of the anti-IgG component of Anti-Human Globulin (AHG). AHG that does not agglutinate properly washed red blood cells in an antiglobulin test should remain in the active state and should be capable of agglutinating Checkcell (Weak) when it is added at the final quality control stage of the test. If AHG has been omitted from the test, or it has been inactivated, no agglutination of the Checkcell (Weak) reagent will occur. Tests in those tubes in which Checkcell (Weak) is negative must be repeated and the original results considered invalid.

A negative result obtained with Checkcell (Weak) indicates that the AHG was omitted or neutralized before or during use. The most likely scenario for failure of the Checkcell (Weak) to be positive is neutralization of AHG. Neutralization is usually the result of the introduction of very small amounts of human IgG to AHG either through improper handling or inadequate washing of the antiglobulin test which leads to inactivation or neutralization of the AHG anti-IgG reagent component. Such a scenario could give rise to falsely negative test results. Checkcell (Weak) functions as a positive control mechanism in this scenario. Checkcell (Weak) provides a more sensitive indication of partial neutralization of the anti-IgG component of Anti-Human Globulin.

Formulation

Checkcell (Weak) is a single vial of group O, D-positive red blood cells that have been sensitized with an IgG anti-D. These red blood cells have been prepared as a 2-3% suspension in a buffered preservative solution containing adenosine and adenine to retard hemolysis during the dating period. Chloramphenicol (0.25 mg/mL), neomycin sulfate (0.1 mg/mL) and gentamycin sulfate (0.05 mg/mL) are added as preservatives.

Stability

Checkcell (Weak) has a 67-day expiration based on the earliest date that blood is withdrawn from any donor.

6.5        Device Description − DAT Positive Control Cell

Device Description and Intended Use

Immucor’s DAT Positive Control Cell is designed to be used only with Immucor automated instruments. DAT Positive control cell are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments.

Summary and Principle of Assay Methodology

The antiglobulin (Coombs) test is used for the detection of IgG and/or complement bound to the red blood cells. The Direct Antiglobulin Test (DAT) is used to demonstrate antibodies and/or complement bound to the red blood cells in vivo. Anti-human globulin reagents used in a DAT test can be rendered nonreactive by unbound serum proteins. For this reason, it is essential that appropriate controls be included to ensure proper performance of the antiglobulin reagent. DAT Positive Control Cell, a pool of group O, D-positive red blood cells sensitized (coated) with IgG anti-D, is used as a positive control in the Direct Antiglobulin Test (DAT) when performed on Immucor automated instruments (Galileo, Galileo Neo (NEO) and Galileo Echo).

The DAT Positive Control Cell is used as a positive control for the automated DAT assay (and other automated assays) to verify the addition and the activity of the antihuman globulin reagent, Capture-R Ready Indicator Red Cells. In the automated DAT assay, sample red blood cells are added to Capture-R Select microplate wells to form a red blood cell monolayer. The DAT Positive Control Cell and the corQC™ EXTEND Standard cells are added in duplicate to wells in each run as positive and negative control cells on the Galileo and Galileo Neo automated platforms. The red blood cell monolayer is washed and Capture-R Ready Indicator Red Cells are added to detect the presence of IgG coated on the red blood cell monolayer. Adherence of the indicator cells to the red blood cell monolayer indicates that the red blood cells are sensitized (coated) with IgG, i.e. DAT positive. In a negative test, the absence of detectable IgG on the sample red blood cells causes the indicator cells to pellet to the bottom of the wells as tightly packed red blood cell buttons. If the DAT Positive Control Cell is not positive (for Galileo, Galileo Neo and Galileo Echo) and/or the corQC™ EXTEND Standard cell is not negative (for Galileo and Galileo Neo), then the run is invalidated and no results are reported. A negative result obtained with the DAT Positive Control Cell indicates that the indicator red cells were omitted or neutralized before or during use. The most likely cause for failure of the DAT Positive Control Cell to be positive is the neutralization of Capture-R Ready Indicator Red Cells. Neutralization is usually the result of the introduction of very small amounts of human IgG to Capture-R Ready Indicator Red Cells either through improper handling or inadequate washing which leads to inactivation or neutralization of the indicator red cell anti-IgG reagent component. Such a scenario could give rise to falsely negative test results. DAT Positive Control Cell functions as a positive control mechanism in this scenario.

Formulation

DAT Positive Control Cell is a single vial of group O, D-positive red blood cells. These red blood cells have been prepared as a 4-6% suspension in a buffered preservative solution containing adenosine and adenine to retard hemolysis during the dating period. Chloramphenicol (0.25 mg/mL), neomycin sulfate (0.1 mg/mL) and gentamycin sulfate (0.05 mg/mL) are added as preservatives.

Stability

The DAT Positive Control Cell has a 67-day expiration based on the earliest date that blood is withdrawn from any donor.

6.6        Summary of the Technological Characteristics 

A comparison between the modified devices and the predicate devices is presented in the table below. The devices are compared based on intended use, material, and shelf-life.

Checkcell
Intended UsePredicate (BK820019)Modified Device
Checkcell is used to confirm the validity of negative antiglobulin tests.XX
Used in settings such as blood banks, transfusion services, and clinical laboratories.XX
Material  
A single vial of pooled group O, D+ red cells that have been sensitized with IgG anti-D. These red cells have been prepared as a 4-6% suspension in a buffered preservative solution containing adenosine and adenine to retard hemolysis during the dating period.XX
Red blood cells coated with ------------(b)(4)---------- IgG anti-D(b)(4)(b)(4)
Red blood cells coated with ------------(b)(4)---------- IgG anti-D(b)(4)(b)(4)
Shelf-Life  
67 day expiration dating periodXX

 

Checkcell (Weak)
Intended UsePredicate
(BK040057)
Modified Device
Checkcell is used to confirm the validity of negative antiglobulin tests.XX
Used in settings such as blood banks, transfusion services, and clinical laboratories.XX
Material  
A single vial of pooled group O, D+ red cells that have been sensitized with IgG anti-D. These red cells have been prepared as a 2-3% suspension in a buffered preservative solution containing adenosine and adenine to retard hemolysis during the dating period.XX
Red blood cells coated with ------------(b)(4)---------- IgG anti-D(b)(4)(b)(4)
Red blood cells coated with ------------(b)(4)---------- IgG anti-D(b)(4)(b)(4)
Shelf-Life  
67 day expiration dating periodXX

 

DAT Positive Control Cell
Intended UsePredicate
(BK040023)
Modified Device
Immucor’s DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DAT Positive control cell are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments.XX
Used in settings such as blood banks, transfusion services, and clinical laboratories.XX
Material  
A single vial of pooled group O, D+ red cells that have been sensitized with IgG anti-D. These red cells have been prepared as a 4-6% suspension in a buffered preservative solution containing adenosine and adenine to retard hemolysis during the dating period.XX
Red blood cells coated with ------------(b)(4)---------- IgG anti-D(b)(4)(b)(4)
Red blood cells coated with ------------(b)(4)---------- IgG anti-D(b)(4)(b)(4)
Shelf-Life  
67 day expiration dating periodXX

6.7        Non-Clinical Performance Data

Non-clinical studies verified the performance characteristics of the modified devices over their 67-day expiration dating under various storage conditions. Additional failure mode testing demonstrates that the modified Checkcell/DAT Positive Control Cell and Checkcell (Weak) detect complete and partial neutralization of the anti-IgG component of Anti-Human Globulin due to inadequate washing of antiglobulin tests that is comparable to the current predicate devices. The modified DAT Positive Control Cell demonstrates the expected reactivity when tested on the Galileo, Galileo Neo (NEO) and Galileo Echo.

These studies demonstrated that the modified devices are safe, as effective, and perform as well as or better than the predicate devices.