# K993589: Varelisa RNP Antibodies

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia & Upjohn Co.
- Decided: Nov 26, 1999 after 35 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
No predicates in its family tree.
11 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synelisa® U1-snRNP (68 kDa) Antibodies: named in the summary without a submission number

## Most influential descendants
- K053653: Fidis Connective 10, Model MX006 (2006), 5 descendants of its own
- K151429: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols (2016), 2 descendants of its own
- K083117: Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1 Immunoassay, Models 14-5511-01, 14-5506-01 and 14-5507-01 (2009), 1 descendant of its own
- K082759: Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO Immunoassay (2009), 1 descendant of its own
- K071210: Modification to Fidis Connective 10*, Model MX006 (2007), 1 descendant of its own

## Indications for use
The Varelisa RNP Antibodies EIA kit is designed for the semiquantitative and qualitative determination of RNP antibodies in serum or plasma to aid in the diagnosis of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease (MCTD).

Source page: https://510kreport.com/device/K993589
Methodology: https://510kreport.com/methodology