# K960434: Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530

- Pathway: 510(k) (Traditional)
- Applicant: Incstar Corp.
- Decided: Oct 17, 1996 after 260 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 K896295 (1990). 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)
- K896295: Captia (R) CMV-M, Mercia Diagnostics, Ltd. (1990) Summary page 2.

## Indications for use
The INCSTAR CMV IgM Capture ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgM antibodies to cytomegalovirus in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active CMV infection. The evaluation of paired CMV IgM sera can also aid in determining the stage of active CMV infection.

Source page: https://510kreport.com/device/K960434
Methodology: https://510kreport.com/methodology