# K113143: Immulisa Sci-70 Antibody Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Dec 2, 2011 after 38 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Enzyme linked immunroassay (ELISA) for the qualitative or semi-quantitative detection of ScI-70 antibodies in human serum as an aid in diagnosis of systemic sclerosis / soleroderma in conjunction with other laboratory and clinical fi ndlinrgs.

Source page: https://510kreport.com/device/K113143
Methodology: https://510kreport.com/methodology