BK220779 · Immucor, Inc. Norcross, GA · KSF · May 10, 2023 · Hematology
Device Facts
Record ID
BK220779
Device Name
Capture Positive Control Cell
Applicant
Immucor, Inc. Norcross, GA
Product Code
KSF · Hematology
Decision Date
May 10, 2023
Decision
SESE
Regulation
21 CFR 864.9650
Device Class
Class 2
Indications for Use
Capture Positive Control Cell is used as an antiglobulin control to monitor washing efficacy and reactivity of the Capture-R Ready Indicator Red Cells.
Device Story
Capture Positive Control Cell (CPCC) consists of dried red blood cell membranes coated with IgG anti-D. It is integrated into Capture-R Ready microtitration strips used in blood banking. During testing, the specimen is added to the CPCC well alongside donor red blood cell wells. The device functions as an 'anti-IgG check cell' to verify the performance of the Capture-R Ready Indicator Red Cells (which contain murine monoclonal IgG anti-human IgG). If the assay is functioning correctly, the indicator cells form a second immobilized layer in the CPCC well due to antibody bridging. If the assay fails or washing is insufficient, the indicator cells pellet to the bottom. The device is used on automated platforms (Galileo Echo, Echo Lumena, Galileo NEO, NEO Iris) by laboratory personnel to ensure the validity of antibody screening and identification results, thereby preventing false-negative reports.
Clinical Evidence
No clinical data. Performance was established via non-clinical bench testing comparing three validation lots of the proposed device against the predicate. Testing focused on manufacturing consistency and functional performance (reactivity and failure rates) of the IgG-coated red blood cells.
Technological Characteristics
Reagent: IgG-coated red blood cells (anti-D). Form factor: Dried membranes on microtitration strip wells. Platform: Automated (Galileo Echo, Echo Lumena, Galileo NEO, NEO Iris). Principle: Solid-phase antiglobulin control; antibody bridging causes indicator cell adherence. Sterilization: Not specified.
Indications for Use
Indicated for use as an antiglobulin control in blood banking to monitor washing efficacy and reactivity of Capture-R Ready Indicator Red Cells during antibody detection or identification procedures.
Regulatory Classification
Identification
A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.
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Traditional 510(k) Premarket Notification
IMMUCOR
## 7.0 510(k) Summary
### Date Prepared
October 18, 2022
### 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 Name: Capture Positive Control Cell
Common Name: IgG-coated red blood cells
Device Class: II
Classification: 21CFR§864.9650
Classification Name: Quality control kit for blood banking reagents
Panel: Hematology
Product Code: KSF
Registration Number: 1034569
### Predicate Device Information
Trade/Device Name: DAT Positive Control Cell
Clearance: BK110050 (cleared September 1, 2011)
### Device Descriptions
Capture Positive Control Cell (CPCC) well of certain Capture-R Ready products contains the dried membranes of red blood cells coated with an IgG antibody (anti-D). CPCC is tested along with each specimen tested. The function of the CPCC well is that of an antiglobulin control ("anti-IgG check cells"). In addition to the test wells containing the donor red blood cells for antibody detection or identification, the specimen is also added to the CPCC well to monitor washing efficacy and reactivity of the Capture-R Ready Indicator Red Cells (CRRIRC). The CRRIRC are indicator red blood cells coated with murine monoclonal IgG anti-human IgG antibodies; they function as the anti-human globulin reagent does in a traditional tube test.
Capture Positive Control Cell is manufactured by first coating red blood cells with IgG anti-D using the same process as for manufacture of the predicate DAT Positive Control Cell product. Then, the coated cells are added to the positive control well during the solid-phase manufacturing of Capture-R Ready Reagent Red Blood Cells. The placement of the Capture Positive Control Cell is product specific as described below.
Please note that in the Instructions for Use for Capture-R Ready-Screen (3), Capture-R Ready-ID, Capture-R Ready-ID Extend I, and Capture-R Ready-ID Extend II Capture Positive Control Cell is referred to as "Positive Control Well".
Capture-R Ready-Screen (3)
Traditional 510(k)
Capture Positive Control Cell
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Traditional 510(k) Premarket Notification
IMMUCOR.
Capture-R Ready-Screen (3) (CRRS3) is intended for use in the detection of unexpected IgG antibodies to red blood cells. CRRS3 is manufactured as a three-cell screening set of Group O red cells. The CRRS3 plates consist of 1 x 8 strips with a sequence of wells carrying the bound and dried red blood cell (RBC) membranes of three different group O donors in separate wells followed by a well containing bound and dried IgG antibody-coated RBC membranes. Refer to the illustration below for a depiction of the CRRS3 strip configuration (Capture Positive Control Cell is labeled "Pos. Cont." in the illustration).
# Capture-R Ready-ID (including Capture-R Ready-ID Extend I and Capture-R Ready-ID Extend II)
Capture-R Ready-ID (CRRID) is intended for use in the identification of unexpected IgG antibodies to red blood cells. The CRRID plates consist of 2 x 8 strips with a sequence of wells carrying the bound and dried red blood cell (RBC) membranes.
Capture-R Ready-ID is a panel of group O single donor red cells from 13 different donors which is used in the identification of antibodies to red cells. The red cells are bound to the surfaces of the plastic microtitration strip wells and preserved. The panel includes one well each for an autologous control, Capture Positive Control Cell and negative control. Refer to the diagram below for a depiction of the strip configuration for CRRSID (Capture Positive Control Cell is labeled "Pos. Cont." in the illustration).
# Intended Use
Capture Positive Control Cell is used as an antiglobulin control to monitor washing efficacy and reactivity of the Capture-R Ready Indicator Red Cells.
# Technological Comparison to Predicate Device
Below is a summary of the technological characteristics of Capture Positive Control Cell (proposed device) compared to the predicate device (BK110050).
Traditional 510(k)
Capture Positive Control Cell
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Traditional 510(k) Premarket Notification
IMMUCOR
| Characteristic | Predicate Device | Proposed Device |
| --- | --- | --- |
| **Reagent System** | DAT Positive Control Cell (BK110050) | Capture Positive Control Cell |
| Device Class, Regulation Code | Class II, 21CFR§864.9650 | Same |
| Classification Product Code | KSF | Same |
| Instrument Platform | Galileo Echo, Echo Lumena, Galileo NEO, or NEO Iris | Same |
| Intended 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. | Capture Positive Control Cell is used as an antiglobulin control to monitor washing efficacy and reactivity of the Capture-R Ready Indicator Red Cells. |
| Reagent Cells | Red blood cells coated with (b) (4) human IgG anti-D | Same |
| Monoclonal IgG anti-D Source | (b) (4) | Same |
| Interpretation of results | In the case of a positive result, the migration of the indicator red blood cells to the bottom of the wells is impeded as anti-IgG-IgG complexes are formed on the surface of the immobilized reagent layer. As a consequence of antibody bridging, the indicator cells adhere to the screening cells as a second immobilized layer. In the absence of detectable antigen-antibody interactions (negative result), the indicator red blood cells will not be impeded during their migration and will pellet to the bottom of the wells as tightly agglutinated red blood cell buttons. | Same |
### Non-Clinical Performance
(b) (4) anti-D (b) (4) was successfully used to manufacture Capture Positive Control Cell. The three validation lots of Capture Positive Control Cell manufactured with (b) (4) IgG anti-D (b) (4) demonstrated better performance (lower failure rates) compared with the current CPCC manufactured using (b) (4) IgG anti-D.
### Basis for Claim of Substantial Equivalence
The proposed device is substantially equivalent to the predicate device relative to technological characteristics, formulation, and manufacturing process. The Indications for Use of the proposed device is similar to the legally marketed, predicate device.
Traditional 510(k)
Capture Positive Control Cell
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