# K982603: Quanta Lite Chromatin Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Oct 7, 1998 after 72 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.
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
- K041658: Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200 (2004), 1 descendant of its own
- K083080: Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform (2009), 0 descendants of its own

## Indications for use
An enzyme-linked immunosorbant assay (ELISA) for the semi-quantitative detection of chromatin reactive antibodies in human serum. The presence of anti-chromatin antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of drug-induced lupus (DIL) and systemic lupus erythematosus (SLE).

Source page: https://510kreport.com/device/K982603
Methodology: https://510kreport.com/methodology