# K083117: Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1 Immunoassay, Models 14-5511-01, 14-5506-01 and 14-5507-01

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: May 28, 2009 after 218 days
- Product code: LKO (Anti-Rnp 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 K944172 (1994). 3 ancestors in all.
1 later device descends 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)
- K993589: Varelisa RNP Antibodies, Pharmacia & Upjohn Co. (1999) Summary page 1.
- K944172: Varelisa SCL-70 Antibodies, Elias U.S.A., Inc. (1994) Summary page 1.
- K944173: Varelisa JO-1 Antibodies, Elias U.S.A., Inc. (1994) Summary page 1.

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

## Indications for use
EliATM Jo-1 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Jo-I in human serum and plasma (heparin, EDTA, citrate) as. an aid in the clinical diagnosis of polymyositis / dermatomyositis in conjunction with other laboratoiy and clinical findings. EliATM Jo-1uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250. EliATM RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) 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 RNP70 uses the EIiA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250. EiATM Scl-70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed toScl-70 in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliATM Scl-70 uses the EiA lgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

Source page: https://510kreport.com/device/K083117
Methodology: https://510kreport.com/methodology