(137 days)
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No
The summary describes a traditional immunoassay for detecting rotavirus antigen and does not mention any AI or ML components.
No.
The device is used to detect rotavirus antigen in stool specimens, which is a diagnostic function, not a therapeutic one.
Yes
The device detects the presence of rotavirus antigen in stool specimens, which is a diagnostic indicator for rotavirus infection.
No
The device description clearly indicates it is an assay that detects rotavirus antigen in stool specimens using antibodies and a Solid Phase Receptacle (SPR), which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay "detects the presence of rotavirus antigen in stool specimens." This is a diagnostic test performed in vitro (outside the body) on a biological sample (stool).
- Device Description: The description details the components and mechanism of the assay, which involves antibodies and a detector conjugate to identify a specific antigen in a sample. This is characteristic of an in vitro diagnostic test.
- Anatomical Site: The sample is "stool specimens," which is a biological sample collected from the body for analysis.
- Performance Studies and Key Metrics: The inclusion of performance studies and metrics like sensitivity, specificity, and agreement are standard for evaluating the performance of diagnostic tests.
- Reference Device: The mention of a reference device (K965092 VIDAS Rotavirus Assay) further indicates that this device is being compared to another diagnostic test.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VIDAS Rotavirus (RTV) Assay detects the presence of rotavirus antigen in stool specimens.
Product codes
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Device Description
The VIDAS Rotavirus (RTV) Assay detects the presence of rotavirus antigen in stool specimens. Assay specificity is conferred by the use of two antibodies. The rotavirus antigen is captured on the SPR by a polyclonal anti-rotavirus VP6 antibody, and the detector antibody conjugate is composed of a mouse monoclonal anti-rotavirus VP6 antibody.
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
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Summary of Performance Studies
- False positive results: In studies comparing the VIDAS RTV Assay to one commercially available EIA with resolution of discrepancies by a second EIA, there were 7 false positive samples. This results in a relative specificity of 95.1%, with overall agreement of 96.5%.
- False negative results: In studies comparing the VIDAS RTV Assay to one commercially available EIA with resolution of discrepancies by a second EIA, there were 6 false negative samples. This results in a relative sensitivity of 96.4%, with overall agreement of 96.5%.
- The 13 discrepant samples were further tested with EM. Of the 13 discrepant results, 4 resolved positive and 4 resolved negative in agreement with VIDAS RTV. Three specimens were VIDAS positive and EIA negative, confirmed negative. One specimen was VIDAS negative and EIA positive, confirmed positive. One discrepant result was not tested. The overall agreement of all samples is 94.8%
- Equivocal results: In the studies done to support the VIDAS RTV Assay performance claims, there were 4 equivocal results when following package insert instructions.
- Invalid results: In the studies done to support the VIDAS RTV Assay performance claims, there were no invalid results.
- Cross-reactivity and interference: A panel of approximately 50 microorganisms representing normal enteric flora or common enteric pathogens was tested in the VIDAS RTV Assay. No cross-reactivity or interference was observed with the organisms tested.
- Precision: In the studies done to support the VIDAS RTV Assay performance claims, the intra-assay precision testing showed coefficients of variation of less than 10%. The inter-assay precision testing gave coefficients of variation of less than 10%.
- Limit of detection: The limit of detection is defined as the concentration of organism yielding a test value greater than the negative threshold. The results of testing known concentrations of rotavirus antigen (quantitated via EM) in the VIDAS RTV Assay showed the limit of detection to be approximately 2.3 x 102 viral particles/ ml.
Key Metrics
- Relative specificity: 95.1%
- Relative sensitivity: 96.4%
- Overall agreement (compared to single EIA): 96.5%
- Overall agreement (including EM resolution for discrepant samples): 94.8%
- Intra-assay precision: coefficients of variation of less than 10%
- Inter-assay precision: coefficients of variation of less than 10%
- Limit of detection: approximately 2.3 x 102 viral particles/ml
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3405 Poliovirus serological reagents.
(a)
Identification. Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
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K965092 MAY - 5 1997
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SUMMARY: Safety and Effectiveness Information for the VIDAS Rotavirus Assay
The VIDAS Rotavirus (RTV) Assay detects the presence of rotavirus antigen in stool specimens. It is substantially equivalent to the Cambridge Biotech Rotaclone Rotavirus Diagnostic Kit. Safety and effectiveness issues for qualitative antigen detection enzyme immunoassays such as the VIDAS RTV Assay may include the following:
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- False positive results: In studies comparing the VIDAS RTV Assay to one commercially available EIA with resolution of discrepancies by a second EIA, there were 7 false positive samples. This results in a relative specificity of 95.1%, with overall agreement of 96.5%.
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- False negative results: In studies comparing the VIDAS RTV Assay to one commercially available EIA with resolution of discrepancies by a second EIA, there were 6 false negative samples. This results in a relative sensitivity of 96.4%, with overall agreement of 96.5%.
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- The 13 discrepant samples were furthur tested with EM. Of the 13 discrepant results, 4 resolved positive and 4 resolved negative in agreement with VIDAS RTV. Three specimens were VIDAS positive and EIA negative, confirmed negative. One specimen was VIDAS negative and EIA positive, confirmed positive. One discrepant result was not tested. The overall agreement of all samples is 94.8%
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- Equivocal results: In the studies done to support the VIDAS RTV Assay performance claims, there were 4 equivocal results when following package insert instructions.
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- Invalid results: In the studies done to support the VIDAS RTV Assay performance claims, there were no invalid results.
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- Cross-reactivity and interference: A panel of approximately 50 microorganisms representing normal enteric flora or common enteric pathogens was tested in the VIDAS RTV Assay. No cross-reactivity or interference was observed with the organisms tested.
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- Precision: In the studies done to support the VIDAS RTV Assay performance claims, the intra-assay precision testing showed coefficients of variation of less than 10%. The inter-assay precision testing gave coefficients of variation of less than 10%.
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- Assay specificity is conferred by the use of two antibodies. The rotavirus antigen is captured on the SPR by a polyclonal anti-rotavirus VP6 antibody, and the detector antibody conjugate is composed of a mouse monoclonal anti-rotavirus VP6 antibody .
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- Limit of detection: The limit of detection is defined as the concentration of organism vielding a test value greater than the negative threshold. The results of testing known concentrations of rotavirus antigen (quantitated via EM) in the VIDAS RTV Assay showed the limit of detection to be approximately 2.3 x 102 viral particles/ ml.
The VIDAS RTV Assay must be used according to package insert instructions when testing stool specimens for the presence of rotavirus antigen. Additional information and references may be found in the package insert.