# K935129: Relisa Ena Antibody Screening Test System

- Pathway: 510(k) (Traditional)
- Applicant: Immuno Concepts, Inc.
- Decided: Jan 31, 1994 after 95 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.
9 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K955603: Relsia SS-a/RO & SS/B LA Antibody Test System (1996), 4 descendants of its own
- K972145: Hep-2000 Fluorescent Ana-RO Test System (1998), 2 descendants of its own
- K131791: Ifa 40: Hep-20-10 (2014), 0 descendants of its own
- K060431: Anti Rna Polymerase Iii Elisa Kit, Model 7805 (2006), 0 descendants of its own
- K983924: Hep-2000 Colorzyme Ana-RO Test System, Model 4200-RO (1998), 0 descendants of its own

## Recalls of this device
- Nov 25, 2008 · Not classified · Z-1045-2009: In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.

Source page: https://510kreport.com/device/K935129
Methodology: https://510kreport.com/methodology