PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
Device Facts
| Record ID | K071511 |
|---|---|
| Device Name | PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G |
| Applicant | Focus Diagnostics, Inc. |
| Product Code | MXJ · Microbiology |
| Decision Date | Oct 5, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3305 |
| Device Class | Class 2 |
Indications for Use
The Focus Diagnostics Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software) is intended for qualitatively detecting the presence or absence of human IgG antibodies to HSV-1 and HSV-2 in human sera. The test is indicated for pregnant women and sexually active adults, as an aid for presumptively diagnosing HSV-1 and HSV-2 infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2 infection. The test is not intended for donor screening or for self-testing. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment. The device is for prescription use only.
Device Story
Plexus™ HerpeSelect® HSV 1 and 2 IgG is a multiplexed immunoassay for qualitative detection of human IgG antibodies to HSV-1 and HSV-2 in human sera. Input: patient serum samples. Principle: Antigen bead suspension containing distinct gG-1 and gG-2 beads; three-step procedure involves sample incubation, addition of phycoerythrin-conjugated goat anti-human IgG, and measurement of fluorescence from beads against a cut-off calibrator. Output: qualitative presence/absence of antibodies. Used in clinical laboratories; operated by laboratory technicians. Software automates index calculation from Luminex instrument raw data, replacing manual calculation. Healthcare providers use results as an aid for presumptive diagnosis of HSV infection. Benefits include efficient multiplexed testing for specific HSV types.
Clinical Evidence
Clinical validation included testing 300 pregnant women and 300 sexually active adults across three sites. Sensitivity/specificity for pregnant women: HSV-1 (92.2%/96.5%), HSV-2 (95.5%/94.3%). For sexually active adults: HSV-1 (91.0%/96.5%), HSV-2 (96.3%/97.4%). CDC panel (n=100) showed 100% agreement. Low prevalence population (n=77) and cross-reactivity studies (n=51) were also performed. Reproducibility studies (inter-laboratory, inter-assay, intra-assay, inter-lot) showed %CV generally ≤10% for positives.
Technological Characteristics
Multiplexed immunoassay using antigen-coated beads (gG-1, gG-2). Fluorescence-based detection via Luminex xMAP instrument. Software: Plexus™ Multi Analyte Diagnostic Software v1.0.0.2. Connectivity: supports web-based download of lot-specific factors. Sterilization: not applicable (reagents).
Indications for Use
Indicated for pregnant women and sexually active adults as an aid for presumptively diagnosing HSV-1 and HSV-2 infection. Not for pediatric populations, neonatal screening, immunocompromised patients, point-of-care, or donor screening.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- Plexus™ HerpeSelect® 1 and 2 IgG (K062543)
