# K993839: Ena Profile Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech USA
- Decided: Jan 12, 2000 after 61 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 Trinity Biotech Captia ENA Profile Enzyme-Linked Immunosorbent Assays (ELISA) is intended for the detection of antibodies to individually coated Smith, Sm/RNP, SS-A (Ro), SS-B (La), Scl-70 and Jo-1 in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE), scleroderma, Sjogren’s syndrome (SS), or other systemic rheumatic diseases.

Source page: https://510kreport.com/device/K993839
Methodology: https://510kreport.com/methodology