ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls

The ARCHITECT HSV-2 IgG is an automated chemiluminescent microparticle immunoassay (CMIA) that qualitatively detects IgG antibodies to herpes simplex virus type 2 in human serum and plasma samples. It is intended for testing sexually active adults and expectant mothers to aid in the presumptive diagnosis of HSV-2 infection using the ARCHITECT i System analyzer.

The new device uses chemiluminescent immunoassay technology with automated two-step processing, whereas the predicate (K000238) was a nitrocellulose immunoblot requiring manual visual band evaluation. The new device accepts multiple specimen types (serum and various plasma preparations) compared to the predicate's serum-only requirement, and produces numerical S/CO results (cutoff 1.00) rather than visual interpretation.

Not stated in this summary.

Substantial equivalence is based on identical intended use (qualitative detection of HSV-2 IgG in sexually active adults and pregnant women for presumptive diagnosis), same regulatory classification (Class II, 21 CFR 866.3305), same qualitative assay type, and equivalent clinical performance. The device demonstrated 96.54% positive percent agreement and 96.90% negative percent agreement against a composite comparator of three commercial assays in a 915-sample clinical study, plus 100% agreement with CDC reference samples. Although the technology differs (chemiluminescent vs. immunoblot), the measurands are identical and clinical performance data establish equivalent ability to detect HSV-2 antibodies across both sexually active and pregnant populations.