# K070066: Quanta Lite Rna Pol Iii Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Apr 11, 2007 after 93 days
- Product code: NYO (Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K202541: EliA RNA Pol III (2021), 1 descendant of its own
- K253367: EliA CTD 13 Screen (2026), 0 descendants of its own

## Indications for use
The QUANTA LiteTM RNA Pol III ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-RNA Polymerase III 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 sclerosis (scleroderma) with increased incidence of skin involvement and renal crisis.

Source page: https://510kreport.com/device/K070066
Methodology: https://510kreport.com/methodology