# K213987: ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: Sep 20, 2023 after 639 days
- Product code: MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1)
- Device class: 2
- Regulation: 21 CFR 866.3305
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000238 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000238: HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G, Mrl Diagnostics (2000) Summary page 4.

## Indications for use
The ARCHITECT HSV-1 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of specific IgG antibodies to herpes simplex virus type 1 (HSV-1) in human serum (collected in serum and serum separator tubes) and plasma (collected in dipotassium EDTA, lithium heparin, and lithium heparin plasma separator tubes) on the ARCHITECT i System. The ARCHITECT HSV-1 IgG assay is to be used for testing sexually active adults or expectant mothers to 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 a reactive or nonreactive result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 infection. NOTE: The performance of the ARCHITECT HSV-1 IgG assay has not been established for use in the pediatric population, for neonatal screening, or for testing immunocompromised or immunosuppressed patients. The assay has not been FDA cleared or approved for screening blood or plasma donors.

Source page: https://510kreport.com/device/K213987
Methodology: https://510kreport.com/methodology