# K960367: Incstar Rubella Igg Elisa Assay

- Pathway: 510(k) (Traditional)
- Applicant: Incstar Corp.
- Decided: Oct 24, 1996 after 273 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- 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 K860145 (1986). 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)
- K860145: Rubella Elisa Test System Catalog Number: 4540, Clinical Sciences, Inc. (1986)

## Recalls of this device
- Dec 16, 2009 · Not classified · Z-0922-2010: DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product labeling. The risk is the possibility of delayed pati

## Indications for use
The INCSTAR Rubella IgG ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme-linked immunosorbent assay (ELISA) - technique. When performed according to instructions, the Rubella IgG ELISA test is of value in the determination of rubella immunological status. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of current or recent infection with rubella.

Source page: https://510kreport.com/device/K960367
Methodology: https://510kreport.com/methodology