(396 days)
Vidas CMV IgG Assay
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No
The summary describes a standard immunoassay (MEIA) and does not mention any AI or ML components in the device description, performance studies, or key metrics.
No
The device is described as an immunoassay for the semi-quantitative measurement of IgG antibodies, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as providing "an indication of past or current infection with cytomegalovirus," which is a diagnostic purpose.
No
The device description clearly states it is a Microparticle Enzyme Immunoassay (MEIA), which is a laboratory-based assay involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semi-quantitative measurement of IgG antibodies to cytomegalovirus in serum and plasma... as an indication of past or current infection with cytomegalovirus." This involves testing biological samples in vitro (outside the body) to provide diagnostic information.
- Device Description: The description confirms it's a "Microparticle Enzyme Immunoassay (MEIA)" which is a common type of laboratory test performed on biological samples.
- Performance Studies: The performance studies involve testing "patient specimens" (serum and plasma) using the device and comparing the results to other legally marketed assays. This is characteristic of the evaluation of an IVD.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to examine specimens, such as blood, tissue, or urine, that have been taken from the human body to detect diseases, conditions, or infections. This device clearly fits that description.
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Intended Use / Indications for Use
The AxSYM CMV IgG assav is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomeqalovirus in serum and plasma (EDTA, heparin or sodium citrate) as an indication of past or current infection with cytomegalovirus. This product is not FDA cleared for use in testing blood or plasma donors.
Product codes
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Device Description
The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) performed on the AxSYM random and continuously accessed automated immunoassay analyzer. It uses polystyrene microparticles as a solid phase coated with cytomegalovirus antigen strain AD 169. The conjugate is goat anti-human IgG antibody conjugated to alkaline phosphatase. It is designed for semi-quantitative measurement of IgG antibodies to cytomegalovirus in human serum and plasma (EDTA, sodium citrate, heparin).
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
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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
Twelve hundred (1200) patient specimens were evaluated for the presence of IgG antibody to cytomegalovirus at 2 U.S. laboratories and 1 European laboratory using the AxSYM CMV IgG Antibody assay. In addition, each specimen was tested using a legally marketed EIA (ELFA). Of the 1200 specimens evaluated, 3 were equivocal by EIA (ELFA). Specimens giving equivocal results using EIA (ELFA) were not included in the calculation of relative agreement, relative specificity or relative sensitivity.
Summary of Performance Studies
Study Type: Relative agreement, sensitivity, and specificity comparison with a legally marketed EIA (ELFA).
Sample Size: 1200 patient specimens.
Key Results:
- Relative agreement was 99.8% (1194/1197).
- Relative sensitivity was 99.5% (589/592).
- Relative specificity was 100% (605/605).
- Of the 3 specimens positive by EIA (ELFA) and negative by AxSYM, all 3 were negative after resolution using 2 additional legally marketed assays.
Key Metrics
Relative Sensitivity: 99.5%
Relative Specificity: 100%
Relative Agreement: 99.8%
Predicate Device(s)
Vidas CMV IgG Assay
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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ATTACHMENT A
[510(k)] Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
Image /page/0/Picture/3 description: The image shows a handwritten sequence of characters. The sequence starts with the letter 'K', followed by the numbers '9', '5', '3', '9', '4', and '3'. The characters are written in a simple, slightly rounded style, with consistent line thickness.
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[510(K)] Summary Of Safety And Effectiveness Information Supporting A Substantially Equivalent Determination
The following information as presented in the [510(k)] notification for the AxSYM CMV lgG assay constitutes data supporting a substantially equivalent determination.
[510(K)] Summary Of Device Performance
The AxSYM CMV IgG assav is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomeqalovirus in serum and plasma (EDTA, heparin or sodium citrate) as an indication of past or current infection with cytomegalovirus. This product is not FDA cleared for use in testing blood or plasma donors.
The predicate device used for determination of substantial equivalence is the Vidas CMV IgG Assay, a semi-quantitative automated enzyme-linked fluorescent immunoassay (ELFA). It is intended for use in determination of CMV immunological experience from a single serum sample, or as an aid in the diagnosis of current CMV infection through evaluation of paired sera for a significant increase in CMV-specific IgG. It is not intended for use in testing (screening) blood or plasma donors.
Twelve hundred (1200) patient specimens were evaluated for the presence of IgG antibody to cytomegalovirus at 2 U.S. laboratories and 1 European laboratory using the AxSYM CMV IgG Antibody assay. In addition, each specimen was tested using a legally marketed EIA (ELFA). Of the 1200 specimens evaluated, 3 were equivocal by EIA (ELFA). Specimens giving equivocal results using EIA (ELFA) were not included in the calculation of relative agreement, relative specificity or relative sensitivity. Three specimens vielded discordant results between EIA (ELFA) and AxSYM. The relative agreement was 99.8% (1194/1197). The relative sensitivity was 99.5% (589/592) and the relative specificity was 100% (605/605). Further evaluation of the 3 discordant specimens was performed using 2 additional legally marketed assays. Of the 3 specimens positive by EIA (ELFA) and neqative by AxSYM, all 3 were negative after resolution.
In conclusion, the AxSYM CMV IqG assay is substantially equivalent to the Vidas CMV IgG assay for the detection of IgG antibodies to cytomegalovirus in human serum specimens.
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[510(K)] Summary Of Technological Comparison
The AxSYM CMV IgG Antibody Assay and the Vidas CMV IgG Assay are Substantially Equivalent in that:
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- Both are in vitro immunologic test methods.
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- Both are intended for use in the detection of IgG antibody to cytomegalovirus in human serum.
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- Both are based on the formation of immune complexes between cytomegalovirus antigens and antibody.
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- Both use antigen coated solid phases.
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- Both use a solid phase coated with cytomeqalovirus strain AD 169.
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- Both are semi-quantitative assays.
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- Both conjugates are conjugated to alkaline phosphatase.
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- Both assays are automated.
The AxSYM CMV IgG Antibody Assay and Vidas CMV IgG Assay Differ in that:
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- The AxSYM CMV IgG Antibody assay is an automated microparticle enzyme immunoassay performed with the AxSYM random and continuously accessed automated immunoassay analyzer. The Vidas CMV IgG assay is an automated enzyme-linked fluorescent immunoassay performed with a Vidas (Vitek ImmunoDiadnostic Assay System) instrument.
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- The solid phase used in the AxSYM CMV IgG Antibody assay is a polystyrene microparticle. The solid phase used in the Vidas CMV IgG assay is a Solid Phase Receptacle (SPR).
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- The conjugate in the AxSYM CMV IgG Antibody assay uses goat anti-human IgG antibody conjugated to alkaline phosphatase. The conjugate in the Vidas CMV IgG assay consists of mouse monoclonal anti-human IgG antibody conjugated to alkaline phosphatase.
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- Plasma (EDTA, sodium citrate, and heparin) specimens may be tested in the AxSYM CMV IgG Antibody assay. The use of plasma specimens has not been validated for use in the Vidas CMV IgG assay.
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Comparison of Methods
| Assay Characteristics | AxSYM CMV IgG | Vidas CMV IgG |
|---|---|---|
| Assay Type | Semi-quantitative | Semi-quantitative |
| Antibody Measured | Specific IgG | Specific IgG |
| Assay Principle | MEIA | EIA (ELFA) |
| Solid Phase | polystyrene microparticles | solid phase receptacle |
| Solid Phase Coating | cytomegalovirus antigen | |
| strain AD169 | cytomegalovirus antigen | |
| strain AD169 | ||
| Conjugate | goat anti-human IgG | |
| conjugated to | ||
| alkaline phosphatase | mouse monoclonal | |
| anti-human IgG | ||
| conjugated to | ||
| alkaline phosphatase | ||
| Specimen | Human serum and | |
| plasma (EDTA, sodium | ||
| citrate, heparin) | Human serum | |
| Automation | Performed on automated | |
| instrument | Performed on automated | |
| instrument | ||
| Relative Sensitivity | 99.5% | 100% |
| Relative Specificity | 100% | 98.1% |
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