# K955362: Incstar HSV I/II Igg Fast Elisa Assay

- Pathway: 510(k) (Traditional)
- Applicant: Incstar Corp.
- Decided: Jul 24, 1996 after 245 days
- Product code: IGC (Formalin-Saline)
- Device class: 1
- Regulation: 21 CFR 864.4010
- 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 K852782 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852782: Hsvi - Igg Elisa-Kit, Clinical Sciences, Inc. (1986) Summary page 3.
- K852781: HSV2 - Igg Elisa-Kit, Clinical Sciences, Inc. (1986) Summary page 3.

## Indications for use
The INCSTAR Herpes Simplex Virus Vil IgG “fast” ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to herpes simplex virus type 1 and/or type 2 in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the INCSTAR Herpes Simplex Virus /1l 1gG “fast” ELISA test is of value in the determination of immunological response to infection with HSV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection with herpes simplex virus.

Source page: https://510kreport.com/device/K955362
Methodology: https://510kreport.com/methodology