# K955603: Relsia SS-a/RO & SS/B LA Antibody Test System

- Pathway: 510(k) (Traditional)
- Applicant: Immuno Concepts, Inc.
- Decided: Apr 19, 1996 after 133 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
Longest line of descent: 1 generation back to K935129 (1994). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935129: Relisa Ena Antibody Screening Test System, Immuno Concepts, Inc. (1994) Summary page 1.

## Most influential descendants
- 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

## Indications for use
This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens SS-A/Ro and SS-B/La in human serum.

Source page: https://510kreport.com/device/K955603
Methodology: https://510kreport.com/methodology