SeraQuest Herpes Type 1 Specific IgG

• K Number: K162276
• Device Name: SeraQuest Herpes Type 1 Specific IgG
• Manufacturer: QUEST INTERNATIONAL, INC
• Date Cleared: 2016-10-01 ( 50 days)
• Product Code: MXJ
• Regulation Number: 866.3305
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: K000238

Intended Use

For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 1 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 1 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 infection. The predictive value of a positive result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

Device Description

The SeraQuest® HSV Type 1 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA), which is performed in microwells, at room temperature, and in three thirty minute incubations. The test detects IqG antibodies which are directed against HSV 1 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 1 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values.

AI/ML Overview

The SeraQuest HSV Type 1 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 1 herpes simplex virus (HSV) in human serum.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	SeraQuest HSV Type 1 Specific IgG Performance for Sexually Active Adults	SeraQuest HSV Type 1 Specific IgG Performance for Expectant Mothers	SeraQuest HSV Type 1 Specific IgG Performance with CDC Panel
Sensitivity	92.3% (95% CI: 85.0% to 96.2%)	93.3% (95% CI: 87.3% to 96.6%)	91.3% (42/46 positive, 2 equivocal, 2 negative)
Specificity	91.7% (95% CI: 83.2% to 96.2%)	89.4% (95% CI: 87.1% to 93.7%)	98.1% (53/54 negative, 1 equivocal)

Note: The document does not explicitly state pre-defined acceptance criteria (e.g., "Sensitivity must be >= X%"). Instead, it presents the results of a comparison study against a predicate device and a CDC panel, inferring that the performance achieved is deemed acceptable for substantial equivalence.

2. Sample Size and Data Provenance

   • Test Set (Comparative Study with Predicate Device):
     • Sexually Active Adults: 164 serum samples.
     • Expectant Mothers: 242 serum samples (198 during the first trimester, 19 during the second, 25 during the third).
     • Data Provenance: Prospectively collected, masked, and archived serum samples submitted for HSV serology to clinical laboratories in the Southeastern United States (for sexually active adults) and Northeastern and Southeastern United States (for expectant mothers). This indicates prospective data collection from the United States.
   • Test Set (CDC Panel): 100 serum samples (46 HSV-1 IgG positive, 54 HSV-1 IgG negative).
     • Data Provenance: This is a characterized serum panel provided by the Centers for Disease Control and Prevention (CDC). The specific country of origin for individual samples within the CDC panel is not specified, but the panel itself is a US-based reference.

3. Number of Experts and Qualifications for Ground Truth

   • The document does not mention the use of experts to establish ground truth for the comparative studies.
   • For the comparative study, the predicate device (Focus HerpeSelect® 1 and 2 Immunoblot IgG) served as the reference standard. The ground truth was based on the results of this legally marketed predicate device.
   • For the CDC panel, the CDC HSV 1 Result was used as the ground truth. This panel is composed of "well characterized serum panel" but the methods or experts used by CDC to characterize it are not detailed in this document.

4. Adjudication Method for the Test Set

   • No adjudication method (e.g., 2+1, 3+1) is mentioned for the test set. The results are directly compared to the predicate device's findings or the CDC's characterization of the panel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

   • No MRMC comparative effectiveness study was done. The device is an in-vitro diagnostic (IVD) assay, not an imaging device typically evaluated with human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. Standalone Performance

   • Yes, standalone performance was done. The entire submission details the performance of the SeraQuest HSV Type 1 Specific IgG assay as a standalone device, directly comparing its results to a legally marketed predicate device (immunoblot) and a characterized CDC panel. The performance metrics (sensitivity, specificity, precision) are derived from the device's independent operation.

7. Type of Ground Truth Used

   • Comparative Studies: The ground truth was established by another legally marketed device (predicate device): the Focus HerpeSelect® 1 and 2 Immunoblot IgG.
   • CDC Panel: The ground truth was based on the characterization of the CDC serum panel, which is described as "well characterized."

8. Sample Size for the Training Set

   • The document does not explicitly state a "training set" size. For IVD devices, the development and optimization of the assay might involve internal studies and smaller panels, but these are typically not referred to as a separate "training set" in the same way machine learning models are. The performance studies presented are generally considered validation studies on independent test sets.

9. How the Ground Truth for the Training Set Was Established

   • As no explicit "training set" is mentioned in the context of this IVD device, the method for establishing its ground truth is not provided. The document focuses on the validation of the device against established external references.

Regulation Number and Section

§ 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).