# K072393: Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Dec 7, 2007 after 102 days
- Product code: LSW (Anti-Dna Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K874873 (1988). 1 ancestor in all.
1 later device descends 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)
- K874873: Combigene (TM) Anti-Dna #Kaddz, KADD1, Diagnostic Products Corp. (1988) Summary page 1.

## Most influential descendants
- K253367: EliA CTD 13 Screen (2026), 0 descendants of its own

## Recalls of this device
- Dec 14, 2020 · Class II · Z-1107-2021: Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).

## Indications for use
EliA dsDNA is intended for the in vitro quantitative measurement of lgG antibodies directed to dsDNA in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EllA dsDNA uses the EliA 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/K072393
Methodology: https://510kreport.com/methodology