(102 days)
BK100033, BK170067, BK200542, BK180243
No
The device description mentions a "microprocessor-controlled instrument that fully automates test processing, result interpretation and data management functions," but there is no mention of AI, ML, or advanced image processing techniques typically associated with these technologies. The modifications described are hardware (camera replacement) and software updates that appear to be related to instrument control and user interface, not AI/ML algorithms for interpretation.
No
This device is an in vitro diagnostic test system used for the detection of antibodies to cytomegalovirus (CMV), not for treating a condition or disease.
Yes
The device detects antibodies to cytomegalovirus (CMV) to screen for previous infection, which is a diagnostic purpose.
No
The device description clearly states that Capture-CMV® is a "Solid Phase Red Cell Adherence System" and is used with the NEO Iris® and Galileo NEO® instruments, which are described as microprocessor-controlled instruments that automate test processing. While software is mentioned as being replaced, the core device is a physical test system used in conjunction with hardware instruments.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma."
The term "in vitro" is the key indicator that this device is intended for use outside of the body to examine specimens from the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV® is intended to be used in screening of patients for serological evidence of previous infection by CMV using manual and semiautomated methods, NEO Iris® and Galileo NEO®.
Product codes (comma separated list FDA assigned to the subject device)
LJO
Device Description
Capture-CMV® is a Solid Phase Red Cell Adherence System for the detection of IgG and lgM antibodies to Cytomegalovirus (CMV).
Cytomegalovirus (CMV) is a common human viral pathogen which belongs to the family of herpes viruses. The presence of CMV antibodies in an individual indicates prior infection by the virus. The possibility exists that viral reactivation can occur in such individuals. CMV infection is usually asymptomatic and can persist as a latent or chronic infection.
Viral transmission may occur through transfusion of blood or transplantation of organs from seropositive donors.
lmmunocompromised patients, such as premature neonates, organ transplant patients, and oncology patients, are at greater risk of developing more severe manifestations of CMV infections which can be a major direct or indirect cause of mortality in such patients.
Congenitally infected newborns are especially prone to developing severe cytomegalic inclusion disease (CID). The severe form of CID may be fatal or may cause permanent neurological sequelae, such as mental retardation, deafness, microcephaly, and motor dysfunction. A CMV mononucleosis-type syndrome can result from the transfusion of CMV-infected blood products or the transplantation of CMV-infected donor organs in a seronegative immunocompromised patient. Low birth weight neonates are also at high risk to CMV mononucleosis through transfusion of CMV-infected blood products.
One method of preventing or reducing CMV infection in seronegative immunocompromised patients is to select CMV seronegative blood donors or organ donors that have been tested by serological screening test for antibodies to CMV. Capture-CMV is a solid phase red cell adherence antibody detection system based on procedures of Plapp et al. This procedure is a modification of the mixed agglutination tests for antigen and antibody detection of Coombs et al. and Hogman employing antilgG and IgG-coated red cells as the indicator system. Capture assays for the detection of antibodies to red cells or platelets use anti-lgG-coated red cells as the indicator. Capture-CMV uses anti-IgG plus anti-IgM-coated indicator red cells.
The CMV assay is to be used with NEO Iris® and the Galileo NEO® instruments. The NEO Iris®/Galileo NEO® is a microprocessor-controlled instrument that fully automates test processing, result interpretation and data management functions for the associated assays. The instrument is designed to automate, in addition to the CMV assay, standard immunohematology assays using a microplate-based platform. The originally cleared Galileo NEO® (BK100033) was updated with the following modifications in the current submission:
- The Digi CCD camera module was replaced with an IDS CMOS camera module
- Galileo NEO® software was replaced with NEO Iris® Install Set 3.0.1.0 U software and configuration files
- Galileo NEO® versions of the files OiBxEngl.dll and GalileoLogo.bmp were installed to preserve Galileo NEO® branding in the User Interface and on Reports
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
As noted in the Device Description section above, this submission describes an upgrade of the Galileo NEO® instrument, making it functionally identical to the NEO Iris®. As such, no new studies were performed. Instead, previous data supporting the original clearance of the Capture-CMV® assay on the NEO Iris® (K183571) are presented to demonstrate performance of the upgraded Galileo NEO® system.
The verification of the Capture-CMV® assay was executed under the verification plan for the NEO Iris®, in order to demonstrate equivalency with the Galileo NEO® with software version 3.0.1.
The system verification activities for NEO Iris® were performed as defined in Verification Plan 14-012-VRPLN at Immucor's facility in Norcross, GA. The verification activities included all testing performed related to the CMV assay as appropriate including assay performance for establishing equivalency. All documents generated to support the development, and operations of the system adhere to standard procedures. Testing was executed properly, in accordance with the execution and test procedure instructions. Additional and detailed information about the system verification can be found under the NEO Iris premarket notification BK180243. The results of the verification have been found acceptable to confirm safety and performance.
Clinical Performance Data:
No new clinical studies were performed as the NEO Iris® and the upgraded Galileo NEO® (software version 3.0.1) instruments are functionally identical. The data in the following tables were submitted for clearance of the NEO Iris® in K183571 and are included in the current submission to support clearance of the Capture-CMV® assay when used with the upgraded Galileo NEO® (software version 3.0.1). In these studies, the performance of the Capture-CMV® on NEO Iris® was compared with the performance of the assay on the original Galileo NEO® instrument (cleared in BK100033). For more information refer to K183571: Capture-CMV® (K183571 Letter and K183571 Summary).
In K183571 method comparison studies were performed at four clinical sites, three external sites and internally at Immucor, Inc. for donor specimens and at two external sites and internally at Immucor, Inc. for patient specimens were tested on NEO Iris® and Galileo NEO®. Test results were evaluated for agreement between analyzers. Specimens with discordant results were further tested with a commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV.
Patient Specimens (N=501):
- Site 1: 26 total (18 serum, 8 plasma)
- Site 2: 0 total (0 serum, 0 plasma)
- Site 3: 195 total (70 serum, 125 plasma)
- Site 4: 280 total (212 serum, 68 plasma)
CMV Initial Results - Patient Sample (N=501):
- NEO Iris® Positive, Galileo NEO® Positive: 272
- NEO Iris® Positive, Galileo NEO® Negative: 5
- NEO Iris® Negative, Galileo NEO® Positive: 0
- NEO Iris® Negative, Galileo NEO® Negative: 224
CMV Resolved Results:
- Sensitivity 100.0% (98.7%, 95% 2-sided LCI)
- Specificity 97.8% (95.0%, 95% 2-sided LCI)
Reproducibility:
Study type: Reproducibility was determined using a panel of ten (10) coded samples (five CMV antibody positive and five CMV antibody negative) at three (3) test sites (two external sites and internally at Immucor, Inc.). Samples were tested by two operators, in duplicate on two (2) runs per day for five (5) nonconsecutive days.
Sample size: 1200 total tests
Results:
Site 1:
- Total Tests: 400
- Expected Positive: 200, Observed Positive: 200, % Concordance (95% LCI): 100.0% (98.5%)
- Expected Negative: 200, Observed Negative: 200, % Concordance (95% LCI): 100.0% (98.5%)
Site 2: - Total Tests: 400
- Expected Positive: 200, Observed Positive: 200, % Concordance (95% LCI): 100.0% (98.5%)
- Expected Negative: 200, Observed Negative: 200, % Concordance (95% LCI): 100.0% (98.5%)
Site 3: - Total Tests: 400
- Expected Positive: 200, Observed Positive: 200, % Concordance (95% LCI): 100.0% (98.5%)
- Expected Negative: 200, Observed Negative: 199, % Concordance (95% LCI): 99.5% (97.7%)
Total: - Total Tests: 1200
- Expected Positive: 600, Observed Positive: 600, % Concordance (95% LCI): 100.0% (98.5%)
- Expected Negative: 600, Observed Negative: 599, % Concordance (95% LCI): 99.8% (99.2%)
Specificity and Cross-reactivity:
- EBV (VCA) Epstein-Barr Virus (Viral Capsid Antigen) (Number: 16): Capture-CMV Positive: 0
- HSV - Herpes Simplex Virus Type I (Number: 10), Type II (Number: 13), IgM* (Number: 2) (*HSV Type not specified): Capture-CMV Positive: 0
- Hepatitis A (Number: 5): Capture-CMV Positive: 1
- Parvovirus B19 (Number: 4): Capture-CMV Positive: 0
- ANA - Anti-Nuclear Antibodies (Number: 11): Capture-CMV Positive: 1
- RF - Rheumatoid Factor (Number: 10): Capture-CMV Positive: 0
- VZ - Varicella Zoster (Number: 8): Capture-CMV Positive: 0
- Rubella (Number: 8): Capture-CMV Positive: 0
- Toxoplasma gondii (Number: 4): Capture-CMV Positive: 0
Key results: The non-clinical and clinical study data demonstrate that the Capture-CMV® assay used with Galileo NEO® instrument is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity 100.0% (98.7%, 95% 2-sided LCI)
Specificity 97.8% (95.0%, 95% 2-sided LCI)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
BK100033, BK170067, BK200542, BK180243
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).
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March 22, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of an eagle. The text on the right is in blue and white, with "FDA" in a larger font size than the rest of the text.
Immucor, Inc. Steven Appel Senior Principal Regulatory Affairs Specialist 3130 Gateway Drive Norcross, Georgia 30071
Re: K203612
Trade/Device Name: Capture-CMV Regulation Number: 21 CFR 866.3175 Regulation Name: Cytomegalovirus serological reagents Regulatory Class: Class II Product Code: LJO Dated: September 16, 2020 Received: December 10, 2020
Dear Steven Appel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Maria Garcia, Ph.D. Branch Chief Division of Microbiological Devices Office of Health Technologies 7 Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203612
Device Name Capture-CMV®
Indications for Use (Describe)
Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV® is intended to be used in screening of patients for serological evidence of previous infection by CMV using manual and semiautomated methods, NEO Iris® and Galileo NEO®.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Date Prepared
March 16, 2021
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/Device Name: | Capture-CMV® |
|---|---|
| Common Name: | CMV Antibody Screen |
| Classification Name: | Cytomegalovirus serological reagents |
| Unique Device Identifier (UDI): | 10888234002154 |
Device Class
| Regulatory Class: | ============================================================================================================================================================================== |
|---|---|
| Product Code: | LJO |
| Regulation Number: | 21 C.F.R. §866.3175 |
| Regulation Medical Specialty: | Microbiology |
| Review Panel: | Microbiology |
Predicate Device Information
| Trade/Device Name: | Capture-CMV® |
|---|---|
| Clearance: | K183571 (cleared February 4, 2019) |
Purpose of the Submission
To demonstrate performance of the Capture-CMV® assay on the upgraded Galileo NEO® (Software version 3.0.1) instrument. This is an upgrade of the Galileo NEO® (BK100033) to match the NEO Iris® instrument that was cleared via BK183571. With these changes the Galileo NEO® and NEO Iris® instruments are functionally identical; the only differences are model name, the exterior colors of the instruments, and whether the software indicates the device name as NEO Iris® or Galileo NEO®. Thus, no new studies were performed to evaluate the performance of Capture-CMV®. Instead, previous data supporting the original clearance of the Capture-CMV® assay on the NEO lris® is presented.
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Image /page/4/Picture/1 description: The image shows the word "IMMUCOR" in purple letters. The letters are bold and sans-serif. There is a gradient of colors above the word, from blue to green to yellow to red. The word is likely the name of a company or organization.
Device Description
Capture-CMV® is a Solid Phase Red Cell Adherence System for the detection of IgG and lgM antibodies to Cytomegalovirus (CMV).
Cytomegalovirus (CMV) is a common human viral pathogen which belongs to the family of herpes viruses. The presence of CMV antibodies in an individual indicates prior infection by the virus. The possibility exists that viral reactivation can occur in such individuals. CMV infection is usually asymptomatic and can persist as a latent or chronic infection.
Viral transmission may occur through transfusion of blood or transplantation of organs from seropositive donors.
lmmunocompromised patients, such as premature neonates, organ transplant patients, and oncology patients, are at greater risk of developing more severe manifestations of CMV infections which can be a major direct or indirect cause of mortality in such patients.
Congenitally infected newborns are especially prone to developing severe cytomegalic inclusion disease (CID). The severe form of CID may be fatal or may cause permanent neurological sequelae, such as mental retardation, deafness, microcephaly, and motor dysfunction. A CMV mononucleosis-type syndrome can result from the transfusion of CMV-infected blood products or the transplantation of CMV-infected donor organs in a seronegative immunocompromised patient. Low birth weight neonates are also at high risk to CMV mononucleosis through transfusion of CMV-infected blood products.
One method of preventing or reducing CMV infection in seronegative immunocompromised patients is to select CMV seronegative blood donors or organ donors that have been tested by serological screening test for antibodies to CMV. Capture-CMV is a solid phase red cell adherence antibody detection system based on procedures of Plapp et al. This procedure is a modification of the mixed agglutination tests for antigen and antibody detection of Coombs et al. and Hogman employing antilgG and IgG-coated red cells as the indicator system. Capture assays for the detection of antibodies to red cells or platelets use anti-lgG-coated red cells as the indicator. Capture-CMV uses anti-IgG plus anti-IgM-coated indicator red cells.
The CMV assay is to be used with NEO Iris® and the Galileo NEO® instruments. The NEO Iris®/Galileo NEO® is a microprocessor-controlled instrument that fully automates test processing, result interpretation and data management functions for the associated assays. The instrument is designed to automate, in addition to the CMV assay, standard immunohematology assays using a microplate-based platform. The originally cleared Galileo NEO® (BK100033) was updated with the following modifications in the current submission:
- The Digi CCD camera module was replaced with an IDS CMOS camera module ●
- . Galileo NEO® software was replaced with NEO Iris® Install Set 3.0.1.0 U software and configuration files
- . Galileo NEO® versions of the files OiBxEngl.dll and GalileoLogo.bmp were installed to preserve Galileo NEO® branding in the User Interface and on Reports
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For detailed technological characteristics of the upgraded Galileo NEO® and the NEO Iris® instrument refer to the following clearance documents: BK100033, BK170067, K183571 and BK200542.
Intended Use
Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV® is intended to be used in screening of patients for serological evidence of previous infection by CMV using manual and semi-automated methods, NEO Iris® and Galileo NEO®.
Substantial Equivalence and Comparison to the Predicate Device
| Technological
Characteristics | PREDICATE DEVICE: K183571
(Capture-CMV cleared for use on NEO Iris on
February 4, 2019) | PROPOSED DEVICE: Capture-CMV
(for use on Galileo NEO with software version 3.0.1) |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Capture-CMV® is an in vitro qualitative solid phase
red cell adherence test system for the detection of
antibodies (IgG plus IgM) to cytomegalovirus (CMV)
in human serum or plasma. Capture-CMV is
intended to be used in screening of blood and
plasma donors or patients for serological evidence of
previous infection by CMV. | Capture-CMV® is an in vitro qualitative solid phase
red cell adherence test system for the detection of
antibodies (IgG plus IgM) to cytomegalovirus (CMV)
in human serum or plasma. Capture-CMV® is
intended to be used in screening of patients for
serological evidence of previous infection by CMV
using manual and semi-automated methods, NEO
Iris® and Galileo NEO®. |
| Test Principle | Serum or plasma samples are added to the viral-
coated wells. The samples are incubated for five
minutes; during which antibodies specific for CMV
proteins bind to immobilized viral proteins. Unbound
immunoglobulins are washed from the wells and
replaced with a suspension of anti-IgG- plus anti-
IgM-coated indicator red cells. Centrifugation brings
the indicator red cells in contact with antibodies
bound to the immobilized viral proteins. In the case
of a positive test, the migration of the indicator red
cells to the bottom of the well is impeded as the anti-
IgG and anti- IgM bridges are formed between the
indicator red cells and the viral-bound antibodies. As
a consequence, the indicator red cells adhere over
the surface of the microtitration well. In contrast, in
the absence of viral antigen-antibody interactions
(i.e., a negative test) the indicator red cells are not
impeded during their migration, and pellet to the
bottom of the well as a packed, well-defined cell
button. | Serum or plasma samples are added to the viral-
coated wells. The samples are incubated for five
minutes; during which antibodies specific for CMV
proteins bind to immobilized viral proteins. Unbound
immunoglobulins are washed from the wells and
replaced with a suspension of anti-IgG- plus anti-
IgM-coated indicator red cells. Centrifugation brings
the indicator red cells in contact with antibodies
bound to the immobilized viral proteins. In the case
of a positive test, the migration of the indicator red
cells to the bottom of the well is impeded as the anti-
IgG and anti-IgM bridges are formed between the
indicator red cells and the viral-bound antibodies. As
a consequence, the indicator red cells adhere over
the surface of the microtitration well. In contrast, in
the absence of viral antigen-antibody interactions
(i.e., a negative test) the indicator red cells are not
impeded during their migration, and pellet to the
bottom of the well as a packed, well-defined cell
button. |
| Test Wells | CMV antigen from cytomegalovirus strain AS 169
grown in human foreskin fibroblast cells is
inactivated and coated onto microtitration wells and
dried. | CMV antigen from cytomegalovirus strain AS 169
grown in human foreskin fibroblast cells is inactivated
and coated onto microtitration wells and dried. |
| Capture-CMV
Positive Control
Serum (Weak) | Human serum containing IgG antibodies to CMV
viral proteins. Capture-CMV Positive Control
Serum (weak) is manufactured to represent the
reactivity obtained by weak CMV antibody
positive donors. Weak CMV antibody positive
donors have a titration endpoint of 1:2 or less.
Sodium azide (0.1%) has been added as a
preservative. | Human serum containing IgG antibodies to CMV viral
proteins. Capture-CMV Positive Control Serum
(weak) is manufactured to represent the reactivity
obtained by weak CMV antibody positive donors.
Weak CMV antibody positive donors have a titration
endpoint of 1:2 or less. Sodium azide (0.1%) has
been added as a preservative. |
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Image /page/6/Picture/0 description: The image shows the word "IMMUCOR" in purple text. The letters are capitalized and bolded. Above the text is a colorful graphic that is blurred.
| Technological
Characteristics | PREDICATE DEVICE: K183571
(Capture-CMV cleared for use on NEO Iris on
February 4, 2019) | PROPOSED DEVICE: Capture-CMV
(for use on Galileo NEO with software version 3.0.1) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Capture-CMV
Negative Control
Serum | Human serum containing no antibodies to CMV.
Sodium azide (0.1%) has been added as a
preservative. | Human serum containing no antibodies to CMV.
Sodium azide (0.1%) has been added as a
preservative. |
| Capture-CMV
Indicator Red
Cells | A suspension of human red blood cells coated
with rabbit anti-human IgG plus goat anti-human
IgM molecules. The red blood cells are
suspended in a buffered solution to which
chloramphenicol (0.25 mg/mL), neomycin sulfate
(0.1 mg/mL) and gentamycin sulfate (0.05
mg/mL) have been added as preservatives. | A suspension of human red blood cells coated with
rabbit anti-human IgG plus goat anti-human IgM
molecules. The red blood cells are suspended in a
buffered solution to which chloramphenicol (0.25
mg/mL), neomycin sulfate (0.1 mg/mL) and
gentamycin sulfate (0.05 mg/mL) have been added
as preservatives. |
| Capture-LISS | A low ionic strength solution containing glycine,
bromocresol purple dye and the preservative
sodium azide (0.1%). | A low ionic strength solution containing glycine,
bromocresol purple dye and the preservative sodium
azide (0.1%). |
| Shelf-life | Test wells - 6 months
Controls - 15 months
Capture-LISS - 12 months
Indicator Red Cells - 60 days | Test wells - 6 months
Controls - 15 months
Capture-LISS - 12 months
Indicator Red Cells - 60 days |
| Specimen/
Sample | Serum or plasma | Serum or plasma |
| Test Methods | • Manual/Semi-Automated (BK950029)
• Galileo (BK050050)
• Galileo NEO® (BK1000331 / BK1700672)
• NEO Iris® (K1835713)
- Capture-CMV® cleared for use on the Galileo
NEO®. - Capture-CMV® cleared for use on the Galileo
NEO® (Special 510(k) submission filed to update
analyzer modifications only). - Capture-CMV® cleared for use on NEO Iris® | • Manual/Semi-Automated
• Galileo®
• Galileo NEO®
• NEO Iris®
• Galileo NEO® with software version 3.0.1 |
Performance Data and Testing - Non-Clinical
As noted in the Device Description section above, this submission describes an upgrade of the Galileo NEO® instrument, making it functionally identical to the NEO Iris®. As such, no new studies were performed. Instead, previous data supporting the original clearance of the Capture-CMV® assay on the NEO Iris® (K183571) are presented to demonstrate performance of the upgraded Galileo NEO® system.
The verification of the Capture-CMV® assay was executed under the verification plan for the NEO Iris®, in order to demonstrate equivalency with the Galileo NEO® with software version 3.0.1.
The system verification activities for NEO Iris® were performed as defined in Verification Plan 14-012-VRPLN at Immucor's facility in Norcross, GA. The verification activities included all testing performed related to the CMV assay as appropriate including assay performance for establishing equivalency. All documents generated to support the development, and operations of the system adhere to standard procedures. Testing was executed properly, in accordance with the execution and test procedure instructions. Additional and detailed information about the system verification can be found under the NEO Iris premarket notification BK180243. The results of the verification have been found acceptable to confirm safety and performance.
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Performance Data and Testing - Clinical
No new clinical studies were performed as the NEO Iris® and the upgraded Galileo NEO® (software version 3.0.1) instruments are functionally identical. The data in the following tables were submitted for clearance of the NEO Iris® in K183571 and are included in the current submission to support clearance of the Capture-CMV® assay when used with the upgraded Galileo NEO® (software version 3.0.1). In these studies, the performance of the Capture-CMV® on NEO Iris® was compared with the performance of the assay on the original Galileo NEO® instrument (cleared in BK100033). For more information refer to K183571: Capture-CMV® (K183571 Letter and K183571 Summary).
In K183571 method comparison studies were performed at four clinical sites, three external sites and internally at Immucor, Inc. for donor specimens and at two external sites and internally at Immucor, Inc. for patient specimens were tested on NEO Iris® and Galileo NEO®. Test results were evaluated for agreement between analyzers. Specimens with discordant results were further tested with a commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV.
| Sites | Patient Specimens | ||
|---|---|---|---|
| Total | Serum | Plasma | |
| 1 | 26 | 18 | 8 |
| 2 | 0 | 0 | 0 |
| 3 | 195 | 70 | 125 |
| 4 | 280 | 212 | 68 |
Specimen testing by sites:
| CMV Initial Results
Patient Sample
| N=501 | Galileo NEO® | ||
|---|---|---|---|
| Positive | Negative | ||
| NEO Iris® | Positive | 272 | 5 |
| Negative | 0 | 224 | |
| CMV Resolved Results | Galileo NEO® / | ||
| FDA cleared assay * | |||
| Positive | Negative | ||
| NEO Iris® | Positive | 272 | 5 |
| Negative | 0 | 224 | |
| Sensitivity 100.0% (98.7%, 95% 2-sided LCI) | |||
| Specificity 97.8% (95.0%, 95% 2-sided LCI) |
*Only discordant specimens were tested with IgG/IgM FDA cleared assay. Results are for North America Market assays.
Reproducibility
The reproducibility of Capture-CMV assay on the NEO Iris® was determined using a panel of ten (10) coded samples, five (5) CMV antibody positive and five (5) CMV antibody negative, at three (3) test sites, two external sites and internally at Immucor, lnc. The samples were tested by two operators, in duplicated on two (2) runs per day for five (5) nonconsecutive days. The summary of reproducibility results by site are presented in the following table:
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Traditional 510(k) Premarket Notification
| Concordance by Site | |||||||
|---|---|---|---|---|---|---|---|
| Site | Total | ||||||
| Tests | Expected | ||||||
| Positive | Observed | ||||||
| Positive | % | ||||||
| Concordance | |||||||
| (95% LCI) | Expected | ||||||
| Negative | Observed | ||||||
| Negative | % | ||||||
| Concordance | |||||||
| (95% LCI) | |||||||
| 1 | 400 | 200 | 200 | 100.0% | |||
| (98.5%) | 200 | 200 | 100.0% | ||||
| (98.5%) | |||||||
| 2 | 400 | 200 | 200 | 100.0% | |||
| (98.5%) | 200 | 200 | 100.0% | ||||
| (98.5%) | |||||||
| 3 | 400 | 200 | 200 | 100.0% | |||
| (98.5%) | 200 | 199 | 99.5% | ||||
| (97.7%) | |||||||
| Total | 1200 | 600 | 600 | 100.0% | |||
| (98.5%) | 600 | 599 | 99.8% | ||||
| (99.2%) |
Specificity and Cross-reactivity
The following table summarizes Capture-CMV results when testing samples from subjects with the following lgG antibodies:
| Category of Specimen | Number | Capture-CMV Positive |
|---|---|---|
| EBV (VCA) Epstein-Barr Virus | ||
| (Viral Capsid Antigen) | 16 | 0 |
| HSV - Herpes Simplex Virus | Type I - 10 | |
| Type II - 13 | ||
| IgM* - 2 | 0 | |
| Hepatitis A | 5 | 1 |
| Parvovirus B19 | 4 | 0 |
| ANA - Anti-Nuclear Antibodies | 11 | 1 |
| RF - Rheumatoid Factor | 10 | 0 |
| VZ - Varicella Zoster | 8 | 0 |
| Rubella | 8 | 0 |
| Toxoplasma gondii | 4 | 0 |
*HSV Type not specified
To ensure suitable reactivity and specificity, each assay component lot of the Capture-CMV assay is tested prior to release against sera known to contain specific antibodies to CMV viral proteins, as well as sera known to be free of such antibodies.
Conclusion
The non-clinical and clinical study data demonstrate that the Capture-CMV® assay used with Galileo NEO® instrument is as safe and effective as the predicate device.
Bibliography
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- Plapp FV, Sinor LT, Rachel JM et al. A solid phase antibody screen. Am J Clin Pathol 1984:82:719.
- Coombs RRA, Marks J, Bedford D. Specific mixed agglutination: Mixed 2. erythrocyte-platelet anti-globulin reactions for the detection of platelet antibodies. Br J Haematol 1956;2:84.
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- Hogman C. The principle of mixed agglutination applied to tissue culture systems. Vox Sang 1959;4:12.