# K030681: Quanta Plex Ena Profile 5

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Apr 24, 2003 after 50 days
- Product code: LLL (Extractable Antinuclear 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 QUANTA PlexTMENA Profile 5 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB and Sc1-70 autoantibodies in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus and related connective tissue diseases such as Sjogren's syndrome and scleroderma.

Source page: https://510kreport.com/device/K030681
Methodology: https://510kreport.com/methodology