# K191085: Maverick RNP Assay and Maverick Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Genalyte, Inc.
- Decided: Oct 25, 2019 after 184 days
- Product code: LKO (Anti-Rnp 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Maverick RNP Assay is an immunoassay for the semi-quantitative determination of anti-RNP IgG antibodies in human serum on the Maverick Diagnostic System. The presence of anti-RNP IgG antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of Mixed Connective Tissue Disease (MCTD). The Maverick Diagnostic System (MDS) is an automated immunoassay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology.

Source page: https://510kreport.com/device/K191085
Methodology: https://510kreport.com/methodology