# K955360: Incstar Cytomegalovirus Igg Fast Elisa Assay

- Pathway: 510(k) (Traditional)
- Applicant: Incstar Corp.
- Decided: Jul 22, 1996 after 243 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- 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 K915892 (1992). 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)
- K915892: CMV Igg Elisa Test, Gull Laboratories, Inc. (1992) Summary page 2.

## Indications for use
The INCSTAR CMV IgG “fast” ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to cytomegalovirus in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgG “fast” ELISA test is of value in the determination of immunological response to infection with CMV. 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, reactivated infection, or reinfection with cytomegalovirus.

Source page: https://510kreport.com/device/K955360
Methodology: https://510kreport.com/methodology