# K063565: Quanta Lite SS-a 52 Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Apr 4, 2007 after 127 days
- Product code: OBE (Anti-Ss-A 52 Autoantibodies)
- 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K141655: Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls (2015), 2 descendants of its own
- K213403: Aptiva CTD Essential Reagent (2023), 0 descendants of its own
- K210902: EliA Ro52, EliA Ro60 (2022), 0 descendants of its own
- K140224: Euroimmun Euroline Ena Profile 9AG (Igg) (2014), 0 descendants of its own

## Indications for use
The QUANTA LiteTM SS-A 52 ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-SS-A 52 antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.

Source page: https://510kreport.com/device/K063565
Methodology: https://510kreport.com/methodology