# K964787: Mardx Ena Igg Immunostripe Test System / Mardx Ena Igg Marstripe Test System

- Pathway: 510(k) (Traditional)
- Applicant: Mardx Diagnostics, Inc.
- Decided: Apr 8, 1997 after 130 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) INOVA ENA EIAs for SSA, SSB, Sm, RNP, Jo-1, and Scl-70: named in the summary without a submission number
- (no number) MarDx ENA EIA 6 in 1 Test System: named in the summary without a submission number

## Most influential descendants
- K043067: Ena Igg Beadchip Test System, Array Imaging System, Models 800-00025, Ais 400 (2005), 0 descendants of its own

## Indications for use
The MarDx ENA IgG ImmunoStripe Test System is intended for use in testing human serum for the presence of human IgG to extractable nuclear antigens, as an aid in the diagnosis of autoimmune disease, such as systemic lupus erythematosus, Sjogren syndrome, scleroderma, and myositis.

Source page: https://510kreport.com/device/K964787
Methodology: https://510kreport.com/methodology