(102 days)
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®.
Capture-CMV® is a Solid Phase Red Cell Adherence System for the detection of IgG and lgM antibodies to Cytomegalovirus (CMV).
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
The provided text describes the regulatory clearance of the Immucor Capture-CMV® assay for use on an upgraded Galileo NEO® instrument. The core of the submission is to demonstrate that the upgraded Galileo NEO® is functionally identical to the NEO Iris® instrument, on which the Capture-CMV® assay was previously cleared. Therefore, no new primary studies were conducted for this specific submission; instead, data from the previous K183571 clearance for the NEO Iris® were presented.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the reported performance metrics comparing the NEO Iris® (the predicate for the current submission and the reference for the data) to the original Galileo NEO® or the "FDA cleared assay." The key performance metrics are Sensitivity and Specificity.
| Acceptance Criteria (Implied) | Reported Device Performance (NEO Iris® vs. Galileo NEO® / FDA cleared assay) |
|---|---|
| Sensitivity: High sensitivity expected for detecting CMV antibodies. | 100.0% (95% 2-sided LCI: 98.7%) |
| Specificity: High specificity expected for correctly identifying negative samples. | 97.8% (95% 2-sided LCI: 95.0%) |
| Reproducibility: Consistent results across different sites, operators, and runs. | Positive Concordance: 100.0% (95% LCI: 98.5%) for 600 positive tests across 3 sites. |
| Negative Concordance: 99.8% (95% LCI: 99.2%) for 599 out of 600 negative tests across 3 sites (one site had 99.5% concordance for negative). | |
| Cross-reactivity: Minimal cross-reactivity with other common viral antibodies or autoimmune markers. | No cross-reactivity observed with: EBV, HSV (Type I & II, IgM), Parvovirus B19, RF, VZ, Rubella, Toxoplasma gondii. |
| Limited cross-reactivity observed with: Hepatitis A (1 positive out of 5), ANA (1 positive out of 11). |
2. Sample Size Used for the Test Set and Data Provenance
-
Test Set for Method Comparison (Clinical Performance):
- Patient Specimens: N=501 total.
- Breakdown by type: Not fully specified if all 501 were unique patients or if it includes serum/plasma duplicates. The table shows 26, 0, 195, and 280 patient specimens collected across 4 sites, summing to 501.
- Breakdown by specimen type: Of the 501, 300 were serum and 201 were plasma.
- Data Provenance: The 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." The specific country of origin is not explicitly stated, but Immucor Inc. is based in Norcross, Georgia, implying US-based studies. The studies are retrospective as the data was from a previously cleared device (K183571).
-
Test Set for Reproducibility:
- Panel of Coded Samples: 10 samples (5 CMV antibody positive, 5 CMV antibody negative).
- Total Tests: 1200 (10 samples * 3 sites * 2 operators * 2 runs * 5 days = 1200 total tests). This implies each sample was run multiple times.
-
Test Set for Specificity and Cross-reactivity:
- Various numbers of samples for each category of lgG antibodies. For example, 16 for EBV, 23 for HSV, 5 for Hepatitis A, 11 for ANA, etc. The total number of unique samples for this section is the sum of these values.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. For the method comparison study, discordant specimens were further tested with a "commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV" which served as the reference method or "ground truth resolver" for discordant results.
4. Adjudication Method for the Test Set
For the method comparison study, the adjudication method for discordant results was further testing with a "commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV." This acts as a reference standard to resolve differences between the two systems being compared (NEO Iris® and original Galileo NEO®). This is a form of "tie-breaker" or "ground truth resolution" rather than expert consensus adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic (IVD) assay system and does not involve human readers interpreting images, so the concept of human readers improving with AI assistance is not applicable. The study focuses on the agreement between two automated instrument platforms (NEO Iris® and Galileo NEO®) and their performance against a reference assay.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Yes, this is essentially a standalone performance study. The Capture-CMV® assay, run on the NEO Iris® (and thus, by extension, the upgraded Galileo NEO®), provides a qualitative result (positive or negative) without human intervention in the interpretation of the primary result. The comparison is between two automated systems (NEO Iris® and Galileo NEO®).
7. The Type of Ground Truth Used
The ground truth for the clinical performance assessment (sensitivity and specificity) was established using:
- The results from the original Galileo NEO® instrument as a comparator, specifically for concordance.
- For discordant specimens, a "commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV" was used as the reference standard or "FDA cleared assay." This implies a laboratory-based reference standard or established diagnostic assay as the ground truth.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of an AI/ML device. The Capture-CMV® assay is an in vitro diagnostic test system based on a solid phase red cell adherence principle, not an AI/ML algorithm that requires training data in the conventional sense. The "development" and "verification" activities referenced are typical for IVD device development, not AI model training. Therefore, a sample size for a training set (as understood for AI/ML) is not applicable or provided.
9. How the Ground Truth for the Training Set was Established
As this is not an AI/ML device, the concept of a training set and its ground truth establishment does not apply in the same way. The development and verification process for IVD assays involves establishing performance characteristics against known positive and negative samples, and the consistency of these characteristics across manufacturing lots and instrument platforms.
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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
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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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Image /page/3/Picture/1 description: The image shows the word IMMUCOR in purple font. The letters are large and bold, and they are arranged horizontally. There is a gradient of colors above the word, ranging from purple to blue to green.
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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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
| TechnologicalCharacteristics | PREDICATE DEVICE: K183571(Capture-CMV cleared for use on NEO Iris onFebruary 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 phasered cell adherence test system for the detection ofantibodies (IgG plus IgM) to cytomegalovirus (CMV)in human serum or plasma. Capture-CMV isintended to be used in screening of blood andplasma donors or patients for serological evidence ofprevious infection by CMV. | Capture-CMV® is an in vitro qualitative solid phasered cell adherence test system for the detection ofantibodies (IgG plus IgM) to cytomegalovirus (CMV)in human serum or plasma. Capture-CMV® isintended to be used in screening of patients forserological evidence of previous infection by CMVusing manual and semi-automated methods, NEOIris® and Galileo NEO®. |
| Test Principle | Serum or plasma samples are added to the viral-coated wells. The samples are incubated for fiveminutes; during which antibodies specific for CMVproteins bind to immobilized viral proteins. Unboundimmunoglobulins are washed from the wells andreplaced with a suspension of anti-IgG- plus anti-IgM-coated indicator red cells. Centrifugation bringsthe indicator red cells in contact with antibodiesbound to the immobilized viral proteins. In the caseof a positive test, the migration of the indicator redcells to the bottom of the well is impeded as the anti-IgG and anti- IgM bridges are formed between theindicator red cells and the viral-bound antibodies. Asa consequence, the indicator red cells adhere overthe surface of the microtitration well. In contrast, inthe absence of viral antigen-antibody interactions(i.e., a negative test) the indicator red cells are notimpeded during their migration, and pellet to thebottom of the well as a packed, well-defined cellbutton. | Serum or plasma samples are added to the viral-coated wells. The samples are incubated for fiveminutes; during which antibodies specific for CMVproteins bind to immobilized viral proteins. Unboundimmunoglobulins are washed from the wells andreplaced with a suspension of anti-IgG- plus anti-IgM-coated indicator red cells. Centrifugation bringsthe indicator red cells in contact with antibodiesbound to the immobilized viral proteins. In the caseof a positive test, the migration of the indicator redcells to the bottom of the well is impeded as the anti-IgG and anti-IgM bridges are formed between theindicator red cells and the viral-bound antibodies. Asa consequence, the indicator red cells adhere overthe surface of the microtitration well. In contrast, inthe absence of viral antigen-antibody interactions(i.e., a negative test) the indicator red cells are notimpeded during their migration, and pellet to thebottom of the well as a packed, well-defined cellbutton. |
| Test Wells | CMV antigen from cytomegalovirus strain AS 169grown in human foreskin fibroblast cells isinactivated and coated onto microtitration wells anddried. | CMV antigen from cytomegalovirus strain AS 169grown in human foreskin fibroblast cells is inactivatedand coated onto microtitration wells and dried. |
| Capture-CMVPositive ControlSerum (Weak) | Human serum containing IgG antibodies to CMVviral proteins. Capture-CMV Positive ControlSerum (weak) is manufactured to represent thereactivity obtained by weak CMV antibodypositive donors. Weak CMV antibody positivedonors have a titration endpoint of 1:2 or less.Sodium azide (0.1%) has been added as apreservative. | Human serum containing IgG antibodies to CMV viralproteins. Capture-CMV Positive Control Serum(weak) is manufactured to represent the reactivityobtained by weak CMV antibody positive donors.Weak CMV antibody positive donors have a titrationendpoint of 1:2 or less. Sodium azide (0.1%) hasbeen 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.
| TechnologicalCharacteristics | PREDICATE DEVICE: K183571(Capture-CMV cleared for use on NEO Iris onFebruary 4, 2019) | PROPOSED DEVICE: Capture-CMV(for use on Galileo NEO with software version 3.0.1) |
|---|---|---|
| Capture-CMVNegative ControlSerum | Human serum containing no antibodies to CMV.Sodium azide (0.1%) has been added as apreservative. | Human serum containing no antibodies to CMV.Sodium azide (0.1%) has been added as apreservative. |
| Capture-CMVIndicator RedCells | A suspension of human red blood cells coatedwith rabbit anti-human IgG plus goat anti-humanIgM molecules. The red blood cells aresuspended in a buffered solution to whichchloramphenicol (0.25 mg/mL), neomycin sulfate(0.1 mg/mL) and gentamycin sulfate (0.05mg/mL) have been added as preservatives. | A suspension of human red blood cells coated withrabbit anti-human IgG plus goat anti-human IgMmolecules. The red blood cells are suspended in abuffered solution to which chloramphenicol (0.25mg/mL), neomycin sulfate (0.1 mg/mL) andgentamycin sulfate (0.05 mg/mL) have been addedas preservatives. |
| Capture-LISS | A low ionic strength solution containing glycine,bromocresol purple dye and the preservativesodium azide (0.1%). | A low ionic strength solution containing glycine,bromocresol purple dye and the preservative sodiumazide (0.1%). |
| Shelf-life | Test wells - 6 monthsControls - 15 monthsCapture-LISS - 12 monthsIndicator Red Cells - 60 days | Test wells - 6 monthsControls - 15 monthsCapture-LISS - 12 monthsIndicator 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)1) Capture-CMV® cleared for use on the GalileoNEO®.2) Capture-CMV® cleared for use on the GalileoNEO® (Special 510(k) submission filed to updateanalyzer modifications only).3) 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 ResultsPatient SampleN=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 | TotalTests | ExpectedPositive | ObservedPositive | %Concordance(95% LCI) | ExpectedNegative | ObservedNegative | %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 - 10Type II - 13IgM* - 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.
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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).