# K980759: Diamedix IS-Ena-6 Screen Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Apr 23, 1998 after 55 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) Zeus Scientific ENA Screen, ELISA Test System: named in the summary without a submission number

## Recalls of this device
- Jun 8, 2011 · Not classified · Z-1620-2012: On 06/08/2011 Diamedix Corporation initiated a recall of Is-ENA-6 Screen Test Kit, Catalog # 720-320 Master Lot S0000, Exp. Date May 31, 2012. The labeling on the kit box has an expiration date of 201

## Indications for use
For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders.This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody. These reagents can be used either manually or in conjunction with the MAGO® or MAGO® PLUS Automated EIA Processors.

Source page: https://510kreport.com/device/K980759
Methodology: https://510kreport.com/methodology