(195 days)
lmmunoassay for the in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lesions or associated disease manifestations, particularly for primary infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
This test is not FDA-cleared for screening blood or plasma donors.
The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients or for use at point-of-care facilities.
The Elecsys HSV-2 IgG immunoassay makes use of a sandwich test principle using biotinylated recombinant HSV-2-specific antigens and HSV-2-specific recombinant antigens labeled with a ruthenium complex. The Elecsys HSV-2 IgG immunoassay is intended for the qualitative determination of lgG class antibodies to HSV-2 in human serum and in the presumptive diagnosis of HSV-2 infection. It is intended for use on the cobas e immunoassay analyzers. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration.
The Elecsys HSV-2 IgG (08948887160) device is an immunoassay for the qualitative determination of IgG class antibodies to HSV-2. The study involved a comparison against a predicate device (K121895).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity thresholds) that were required for clearance or the corresponding reported device performance values in a quantitative manner. Instead, it focuses on demonstrating substantial equivalence to a predicate device and improved technical characteristics.
The "Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)" section is where such data would typically be found, but it is not expanded upon in the provided text. The submission describes technological improvements to biotin tolerance and streptavidin interference, which are performance characteristics.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be detailed within the non-clinical and/or clinical test summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided text does not specify the number of experts used to establish the ground truth for the test set or their qualifications. For an immunoassay, the ground truth would typically be established by a reference method or a panel of samples with confirmed HSV-2 status, rather than expert interpretation of images or clinical cases.
4. Adjudication Method
The provided text does not specify any adjudication method. For an immunoassay, adjudication might not be relevant in the same way as for subjective diagnostic tasks like image interpretation, as the result is typically a quantitative measurement converted to a qualitative outcome.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, as this device is an immunoassay and does not involve human readers interpreting cases in the same way an imaging diagnostic device would. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone Performance
The device itself is a standalone immunoassay. Its performance is measured directly through its ability to detect HSV-2 IgG antibodies. While the document mentions "cobas e immunoassay analyzers" for its use, the performance described would implicitly be the standalone performance of the assay on these automated platforms. The provided text does not provide quantitative standalone performance metrics such as sensitivity and specificity.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated in the provided text. However, for an immunoassay for antibodies, the ground truth for test samples would typically be established by:
- Reference methods: Such as Western blot, more sensitive PCR, or another highly validated immunoassay.
- Clinical diagnosis and follow-up: Including a history of recurrent genital lesions confirmed by viral culture or PCR.
- Well-characterized seroconversion panels: For sensitivity studies.
Given that this is an immunoassay for IgG antibodies to HSV-2, the ground truth would likely involve confirmed HSV-2 infection status based on established laboratory methods and/or clinical presentation.
8. Sample Size for the Training Set
The provided text does not specify the sample size for the training set. Immunoassays are typically "trained" during their development and optimization phases using numerous characterized samples to establish appropriate cut-offs and ensure performance.
9. How the Ground Truth for the Training Set Was Established
The provided text does not specify how the ground truth for the training set was established. Similar to the test set, it would have involved established laboratory reference methods and/or clinical confirmation of HSV-2 status. For an immunoassay, training involves optimizing reagent concentrations, reaction conditions, and setting cut-off values using panels of known positive and negative samples.
§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).