SeraQuest Herpes Type 1 Specific IgG

K162276 · Quest International, Inc. · MXJ · Oct 1, 2016 · Microbiology

Device Facts

• Record ID: K162276
• Device Name: SeraQuest Herpes Type 1 Specific IgG
• Applicant: Quest International, Inc.
• Product Code: MXJ · Microbiology
• Decision Date: Oct 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3305
• Device Class: Class 2

Indications for 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 or negative 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 Story

SeraQuest HSV Type 1 Specific IgG is an ELISA for qualitative detection of human IgG antibodies to HSV-1 in human serum. Device uses recombinant HSV gG-1 antigen coated on polystyrene microwells. Patient samples are diluted and incubated in wells; if HSV-1 IgG is present, it binds to the antigen. After washing, enzyme-labeled goat anti-human IgG conjugate is added; if IgG is bound, conjugate is immobilized. Substrate (p-nitrophenyl phosphate) is added, converting to a yellow end-product measured photometrically. Results are reported as Index values (<=0.9 negative, 0.9-1.0 equivocal, >=1.0 positive). Used in clinical laboratories by trained personnel. Output aids clinicians in presumptive diagnosis of HSV-1 infection by identifying previous immunologic exposure. Does not determine active infection or disease stage.

Clinical Evidence

Clinical performance evaluated in 164 sexually active adults and 242 expectant mothers compared to a commercial HSV-1 immunoblot. In adults, sensitivity was 92.3% (95% CI: 85.0-96.2) and specificity was 91.7% (95% CI: 83.2-96.2). In expectant mothers, sensitivity was 93.3% (95% CI: 87.3-96.6) and specificity was 89.4% (95% CI: 87.1-93.7). Additional validation performed using a 100-sample CDC serum panel.

Technological Characteristics

Solid-phase ELISA using recombinant HSV gG-1 antigen on polystyrene microwells. Employs alkaline phosphatase-conjugated goat anti-human IgG and p-nitrophenyl phosphate substrate. Readout is spectrophotometric. Requires three 30-minute incubations at room temperature. Manual or automated processing (though performance not established for automated equipment).

Indications for Use

Indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 infection. Not for use in immunocompromised patients, pediatric patients, or for screening blood/plasma donors.

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).

Submission Summary (Full Text)

{0}

1

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: K162276

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.