# K991657: Quanta Lite Ana Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jun 17, 1999 after 35 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
An enzyme-linked immunosorbant assay for the semi-quantitative detection of anti-nuclear antibodies (ANA) in human serum. The presence of ANA can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of rheumatic diseases such as systemic lupus erythematosus, Sjdégren's syndrome, scleroderma, and mixed connective tissue disease. The assay collectively detects, in one well, total ANA against chromatin (dsDNA and histones), Sm/RNP, SS-A, SS-B, Scl-70, centromere, and PCNA as well as antibodies against diagnostically important cytoplasmic antigens such as Jo-1, mitochondria (M-2) and ribosomal-P protein. Sera positive for unidentified antigens by the traditional indirect immunofluorescent antibody test on HEp-2 cells may also be detected.

Source page: https://510kreport.com/device/K991657
Methodology: https://510kreport.com/methodology