# K072149: Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Jan 15, 2008 after 165 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
Longest line of descent: 1 generation back to K880736 (1988). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961913: Quanta Lite Ena 6 Elisa, Inova Diagnostics, Inc. (1996) Summary page 1.
- K880736: Nova Lite (TM) Ana, Inova Diagnostics, Inc. (1988) Summary page 1.

## Most influential descendants
- K190710: EliA SymphonyS Immunoassay (2019), 1 descendant of its own
- K253367: EliA CTD 13 Screen (2026), 0 descendants of its own

## Indications for use
EllA Symphony Immunoassay is intended for the in vitro, qualitative measurement of antinuclear IgG antibodies in human serum and plasma (heparin, EDTA and citrate). EliA Symphony Immunoassay is based on human recombinant UIRNP (RNP 70, A, C), SS-A/Ro (60 kDa, 52 kDa), SS-B/La, Centromere B, Scl-70, Jo-I proteins and native purified Sm proteins as antigen and is useful as an aid in the clinical diagnosis of patients with systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sj6gren's syndrome, scleroderma and polymyositis/dermatomyositis, in conjunction with other laboratory and clinical findings. EllA Symphony Immunoassay uses the EllA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250. EliA ANA Control is intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodies (ANA) with ImmunoCAP 100 or ImmunoCAP 250 using the EliA IgG method.

Source page: https://510kreport.com/device/K072149
Methodology: https://510kreport.com/methodology