# K981237: Quanta Lite Ribosome P Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jun 5, 1998 after 63 days
- Product code: MQA (Anti-Ribosomal P Antibodies)
- 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.
12 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053653: Fidis Connective 10, Model MX006 (2006), 5 descendants of its own
- K151429: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols (2016), 2 descendants of its own
- K202540: EliA Rib-P (2021), 1 descendant of its own
- K123261: Euroimmun Anti-NRNP/SM Elisa (Igg) (2013), 1 descendant of its own
- K071210: Modification to Fidis Connective 10*, Model MX006 (2007), 1 descendant of its own

## Indications for use
An enzyme linked immunosorbant assay (ELISA) for the semi-quantitative detection of ribosome antibody in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE) and other related connective tissue diseases.

Source page: https://510kreport.com/device/K981237
Methodology: https://510kreport.com/methodology