# K081687: Liaison HSV-2 Type Specific Igg Assay, Control HSV-2 Igg

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Nov 10, 2008 after 146 days
- Product code: MYF (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2)
- Device class: 2
- Regulation: 21 CFR 866.3305
- Recalls of this device: 1 (0 Class I)
- 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 1.

## Recalls of this device
- Dec 13, 2023 · Class II · Z-0815-2024: DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may pro

## Indications for use
The LIAISON® HSV-2 Type Specific IgG assay is a chemiluminescent immunoassay (CLIA) to be used with the LIAISON® Analyzer for the qualitative determination of type specific IgG antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The assay is indicated for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection. The LIAISON® HSV-2 Type Specific IgG assay has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised patients. The assay is neither FDA cleared nor approved for testing blood or plasma donors. The LIAISON® Control HSV-2 (negative and positive) are intended for use as assayed quality control samples to monitor the performance of the LIAISON® HSV-2 Type Specific IgG assay. The LIAISON® HSV-2 Type Specific IgG assay is a chemiluminescent immunoassay (CLIA) to be used with the LIAISON® Analyzer for the qualitative determination of type specific IgG antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The assay is indicated for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection. The LIAISON® HSV-2 Type Specific IgG assay has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised patients. The assay is neither FDA cleared nor approved for testing blood or plasma donors. The LIAISON® Control HSV-2 (negative and positive) are intended for use as assayed quality control samples to monitor the performance of the LIAISON® HSV-2 Type Specific IgG assay.

Source page: https://510kreport.com/device/K081687
Methodology: https://510kreport.com/methodology