(45 days)
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No
The device description details a solid phase red cell adherence test system based on chemical and physical reactions, with no mention of computational analysis, algorithms, or learning processes.
No
The device is an in vitro diagnostic test system for detecting antibodies to CMV, intended for screening purposes for evidence of previous infection, not for treating or rehabilitating patients.
Yes
The device, Capture-CMV®, is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies to cytomegalovirus in human serum or plasma, intended for screening of blood and plasma donors or patients for serological evidence of previous infection by CMV. This directly aligns with the definition of a diagnostic device, which is used to diagnose diseases or conditions.
No
The device description clearly outlines a physical in vitro diagnostic test system involving chemical reactions, red blood cells, and microtitration wells. It is a hardware-based assay.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it 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." This clearly indicates it is used to examine specimens taken from the human body in vitro (outside the body) to provide information about a physiological state (presence of CMV antibodies).
- Device Description: The description details a laboratory test procedure involving human serum or plasma samples, viral-coated wells, and indicator red cells to detect antibodies. This is a typical description of an in vitro diagnostic test.
- Intended User / Care Setting: The intended use in "screening of blood and plasma donors or patients" further supports its use in a clinical or laboratory setting for diagnostic or screening purposes.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens, including blood, tissue, and urine, taken from the human body to provide information for diagnosis, monitoring, or screening. The description and intended use of the Capture-CMV® system perfectly align with this definition.
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 blood and plasma donors or patients for serological evidence of previous infection by CMV.
Product codes (comma separated list FDA assigned to the subject device)
LJO
Device Description
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.
Immunocompromised 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 anti-IgG and IgM-coated red cells as the indicator system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification studies and other studies were performed to demonstrate design inputs for the Capture-CMV assay on the NEO Iris were met and to demonstrate equivalence in performance between the predicate device, Capture-CMV testing on the Galileo Neo" and the proposed device, Capture-CMV testing on the NEO Iris™.
Method comparison studies were performed at three clinical sites, two external sites and internally at Immucor, Inc. 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.
Sample Size: 501 patient samples.
Sensitivity 100.0% (98.7%, 95% 2-sided LCI)
Specificity 97.8% (95.0%, 95% 2-sided LCI)
The reproducibility of the Capture-CMV assay on 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, Inc. The samples were tested by two operators, in duplicated on two (2) runs per day for five (5) nonconsecutive days.
Total Tests: 1200 (400 per site)
Expected Positive: 600 (200 per site)
Observed Positive: 600 (200 per site)
% Concordance (95% LCI) for Positive: 100.0% (98.5%)
Expected Negative: 600 (200 per site)
Observed Negative: 599 (Site 1: 200, Site 2: 200, Site 3: 199)
% Concordance (95% LCI) for Negative: 99.8% (99.2%)
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.
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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).
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§ 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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February 4, 2019
Immucor, Inc. Howard Yorek Senior Director, Regulatory Affairs 3130 Gateway Drive Norcross, Georgia 30071
Re: K183571
Trade/Device Name: Capture-CMV Regulation Number: 21 CFR 866.3175 Regulation Name: Cytomegalovirus serological reagents Regulatory Class: Class II Product Code: LJO Dated: December 14, 2018 Received: January 8, 2019
Dear Howard Yorek:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Steven R. Gitterman -S for
Uwe Scherf, Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183571
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 blood and plasma donors or patients for serological evidence of previous infection by CMV.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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Applicant Information
510(k) Owner: Immucor, Inc. Address: 3130 Gateway Drive Norcross, GA 30071 Telephone: 770-441-2051 Fax: 770-441-3081 Contact: Howard Yorek Date Prepared: December 14, 2018 Device Information
Device Trade Name: Device Common Name: Device Classification Name: Device Classification: Classification Product Code: Regulation Number: Predicate Device: 510(k) Number:
Capture-CMV® CMV Antibody Screen Cytomegalovirus serological reagents Class II LJO 21 CFR 866.3175 Capture-CMV (K910003) K183571
Device Description and Intended Use
Summary of the Test
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.
Immunocompromised 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
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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 anti-IgG and IgM-coated red cells as the indicator system.
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.
| Technological
| Characteristics | Predicate Device | Proposed Device | Comparison |
|---|---|---|---|
| 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 blood and | |||
| plasma donors or patients for | |||
| serological evidence of previous | |||
| infection by CMV. | Equivalent - | ||
| Indications for use | |||
| add NEO Iris for | |||
| diagnostic | |||
| screening | |||
| 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 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 | |||
| test well. In contrast, in the | |||
| absence of viral antigen-antibody | |||
| interactions (i.e. a negative test) | |||
| the indicator red cells are not | 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 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 | |||
| test well. In contrast, in the | |||
| absence of viral antigen-antibody | |||
| interactions (i.e. a negative test) | |||
| the indicator red cells are not | Identical | ||
| Test Wells | impeded during their migration, and pellet to the bottom of the well as a packed, well-defined cell button. | ||
| CMV antigen from cytomegalovirus strain AS 169 grown in human foreskin fibroblast cells is inactivated and coated onto microtitration wells and dried. | Identical | ||
| 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 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. | Identical | |
| 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 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. | |||
| Capture-CMV | |||
| Negative Control | |||
| Serum | Human serum containing no antibodies to CMV viral proteins. Sodium azide (0.1%) has been added as a preservative. | Identical | |
| Human serum containing no antibodies to CMV viral proteins. 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 antibodies. 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. | Identical | |
| A suspension of human red blood cells coated with rabbit anti-human IgG plus goat anti-human IgM antibodies. 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%). | Identical | |
| 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 | Identical | ||
| Test wells - 6 months | |||
| Controls - 15 months | |||
| Capture LISS – 12 months | |||
| Indicator Red Cells – 60 days | |||
| Specimen | Serum or plasma | Identical | |
| Serum or plasma | |||
| Test Methods | Manual/Semi-automated diagnostic screening (K910003) | ||
| Manual/Semi-automated donor screening (BK950029) | |||
| Galileo® donor and diagnostic screening (BK050050) | |||
| Galileo Neo® donor and diagnostic screening (BK100033) | |||
| NEO Iris™ donor screening | Equivalent – | ||
| Indications for use add NEO Iris for diagnostic screening | |||
| Manual/Semi-automated diagnostic screening (K910003) | |||
| Manual/Semi-automated donor screening (BK950029) | |||
| Galileo® donor and diagnostic screening (BK050050) | |||
| Galileo Neo® donor and diagnostic screening (BK100033) | |||
| NEO Iris™ donor screening |
Substantial Equivalence and Comparison to the Predicate Device
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Performance Testing - Non-Clinical
Design verification studies and other studies were performed to demonstrate design inputs for the Capture-CMV assay on the NEO Iris were met and to demonstrate equivalence in performance between the predicate device, Capture-CMV testing on the Galileo Neo" and the proposed device, Capture-CMV testing on the NEO Iris™.
Performance Testing - Clinical
Method comparison studies were performed at three clinical sites, two external sites and internally at Immucor, Inc. 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.
| Galileo Neo | |||
|---|---|---|---|
| CMV Initial Results | |||
| Patient Samples | |||
| N=501 | Positive | Negative | |
| NEO Iris | Positive | 272 | 5 |
| Negative | 0 | 224 | |
| Galileo Neo / | |||
| Anti-CMV PA | |||
| CMV Resolved Results | 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) |
The reproducibility of the Capture-CMV assay on 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, Inc. 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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| 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%) |
Conclusion
The clinical and non-clinical performance data demonstrate substantial equivalence of the NEO Iris Capture-CMV assay in terms of safety, design, performance and reproducibility compared to the predicate device.