# K955361: Incstar Cytomegalovirus Igg 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.
4 later devices descend from it; 1 cites it directly.
0 of 6 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.

## Most influential descendants
- K040290: Diasorin Liaison CMV Igm/Igg (2005), 3 descendants of its own
- K162969: LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set (2017), 0 descendants of its own
- K161526: LIAISON CMV IgM Serum Control Set (2016), 0 descendants of its own
- K161522: LIAISON EBV IgM Serum Control Set (2016), 0 descendants of its own

## Indications for use
The INCSTAR CMV IgG ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of 1gG antibodies to cytomegalovirus in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgG 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/K955361
Methodology: https://510kreport.com/methodology