# K060431: Anti Rna Polymerase Iii Elisa Kit, Model 7805

- Pathway: 510(k) (Traditional)
- Applicant: Mbl International Corporation
- Decided: Jun 19, 2006 after 118 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
Longest line of descent: 3 generations back to K935129 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040200: Mesacup-2 Test Cenp-B, Rhigene, Inc. (2004) Summary page 1.
- K972145: Hep-2000 Fluorescent Ana-RO Test System, Immuno Concepts, Inc. (1998) Summary page 1.

## Indications for use
The anti-RNA Polymerase III ELISA Kit is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of anti-RNA Polymerase III antibodies in human serum. The test result is used as an aid in the diagnosis of Systemic Sclerosis (SSc) in conjunction with the clinical and other laboratory findings. The anti-RNA Polymerase III ELISA Kit is intended for in-vitro diagnostic use.

Source page: https://510kreport.com/device/K060431
Methodology: https://510kreport.com/methodology