Vaccines, Blood & Biologics
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 Use | Predicate (BK820019) | Modified Device |
| Checkcell is used to confirm the validity of negative antiglobulin tests. | X | X |
| Used in settings such as blood banks, transfusion services, and clinical laboratories. | X | X |
| 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. | X | X |
| 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 period | X | X |
| Checkcell (Weak) | ||
|---|---|---|
| Intended Use | Predicate (BK040057) | Modified Device |
| Checkcell is used to confirm the validity of negative antiglobulin tests. | X | X |
| Used in settings such as blood banks, transfusion services, and clinical laboratories. | X | X |
| 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. | X | X |
| 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 period | X | X |
| DAT Positive Control Cell | ||
|---|---|---|
| Intended Use | Predicate (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. | X | X |
| Used in settings such as blood banks, transfusion services, and clinical laboratories. | X | X |
| 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. | X | X |
| 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 period | X | X |
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.
