# K970220: IS-Anti-SM Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Apr 8, 1997 after 77 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: 1 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Helix Diagnostics Enzyme Immunoassay Anti-Sm Antibody Test Kit: named in the summary without a submission number

## Recalls of this device
- Aug 6, 2012 · Class II · Z-0445-2013: Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.

## Indications for use
The assay is intended for use in detecting antibodies to Sm antigen in a single human serum sample. The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders.

Source page: https://510kreport.com/device/K970220
Methodology: https://510kreport.com/methodology