# K860145: Rubella Elisa Test System Catalog Number: 4540

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Sciences, Inc.
- Decided: Jul 14, 1986 after 180 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960367: Incstar Rubella Igg Elisa Assay (1996), 0 descendants of its own
- K960358: Incstar Rubella Igg Fast Elisa Assay (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K860145
Methodology: https://510kreport.com/methodology