(195 days)
Immunoassay for the in vitro qualitative determination of IgG class antibodies to HSV-1 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-1 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 and negative results depends on the population's prevalence and the pretest likelihood of HSV-1.
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, immunocompromised patients, or for use at point-of-care facilities.
The Elecsys HSV-1 IgG immunoassay makes use of a sandwich test principle using biotinylated recombinant HSV-1-specific antigens and HSV-1-specific recombinant antigens labeled with a ruthenium complex. The Elecsys HSV-1 IgG immunoassay is intended for the qualitative determination of IgG class antibodies to HSV-1 in human serum and in the presumptive diagnosis of HSV-1 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 provided text describes the Elecsys HSV-1 IgG immunoassay (08948844160) and its substantial equivalence to a legally marketed predicate device (Elecsys HSV-1 IgG, K120625). However, the document does not contain specific acceptance criteria, reported device performance figures, or detailed study information such as sample sizes, data provenance, ground truth establishment methods, or the results of comparative effectiveness studies.
The document primarily focuses on the regulatory aspects of the device, its intended use, and the technological updates made to improve biotin and streptavidin tolerance.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: Not provided in the document.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not provided.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided.
4. Adjudication method for the test set:
- Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is an immunoassay, not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC study as typically understood for AI in medical imaging would not be applicable, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a standalone immunoassay device. The document mentions: "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." This suggests standalone performance, but no specific study or performance metrics are detailed in this document.
7. The type of ground truth used:
- Not explicitly stated for performance evaluation. For HSV-1 serological assays, ground truth is typically established through a combination of confirmatory methods (e.g., Western blot, PCR, or clinical diagnosis based on symptoms and other tests), but the document does not specify this for its validation.
8. The sample size for the training set:
- Not provided.
9. How the ground truth for the training set was established:
- Not provided.
Summary of Available Information (with placeholders for missing data):
| Information Type | Details / Status |
|---|---|
| Acceptance Criteria | Not explicitly stated in the provided text. |
| Reported Device Performance | Not provided in the provided text. |
| Sample Size (Test Set) | Not provided. |
| Data Provenance (Test Set) | Not provided. |
| Number of Experts for Ground Truth (Test Set) & Qualifications | Not provided. |
| Adjudication Method (Test Set) | Not provided. |
| MRMC Comparative Effectiveness Study | No. This is an immunoassay, not an AI-assisted interpretation device in the context of typical MRMC studies. |
| Standalone Performance Study | The device operates independently by software comparing signals to cutoff values. While the document implies standalone functionality, specific study results or metrics for standalone performance are not provided. |
| Type of Ground Truth Used | Not explicitly stated. Typically, for serological assays, this would involve confirmatory testing methods (e.g., Western blot) or well-characterized clinical diagnosis. |
| Sample Size (Training Set) | Not provided. |
| How Ground Truth for Training Set was Established | Not provided. |
| Purpose of Technological Updates | To improve biotin tolerance from |
§ 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).