# K082759: Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Apr 10, 2009 after 200 days
- Product code: LKJ (Antinuclear Antibody, Antigen, 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 K922830 (1992). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944171: Varelisa Centromere Antibodies, Elias U.S.A., Inc. (1994) Summary page 2.
- K993589: Varelisa RNP Antibodies, Pharmacia & Upjohn Co. (1999) Summary page 2.
- K000312: Varelisa SM Antibodies, Pharmacia & Upjohn Co. (2000) Summary page 2.
- K922830: Quanta Lite SS-a Elisa, Inova Diagnostics, Inc. (1992) Summary page 2.
- K944168: Varelisa LA (SS-B) Antibodies, Elias U.S.A., Inc. (1994) Summary page 2.

## Most influential descendants
- K182353: EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay (2018), 0 descendants of its own

## Indications for use
EliATM Sm is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm 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. EIiATM Sm uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250. EliATM La is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to La in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjogren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA TM La uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250. EliATM Ro is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjdgren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliATM Ro uses the EHiA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250. EliATM UI RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to UIRNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus. (SLE) in conjunction with other laboratory and clinical findings. EliATM U1RNP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250. EliATM CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliATM CENP uses the EIiA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

Source page: https://510kreport.com/device/K082759
Methodology: https://510kreport.com/methodology