# K021257: Ana Line Blot, Catalog Number: Kalabi (20 Tests)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jun 3, 2002 after 45 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 K954723 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954723: Enzyme Immunoassay Ana Screening Test Kit, Helix Diagnostics, Inc. (1995) Summary page 3.

## Indications for use
ANA line Blot is an antinuclear antibody screening test designed to identify IgG antibodies in human serum, against the following cytoplasmic and nuclear antigens, collectively in one strip: centromere, dsDNA, histones, Jo-1,Sci70, SSA (SSA Ro52, SSA R060), SSB, Sm (SmB and SmD), RNP (RNP-70, RNP-A and RNP-C), and Ribosomal RNP ("0). The test is intended as an aid in the diagnosis of autoimmune diseases such as systemic lupus erythematosus (SLE), multiple connective tissue disorders, Sjogren's syndrome, CREST syndrome, scleroderma (progressive systemic sclerosis, PSS), and myositis.

Source page: https://510kreport.com/device/K021257
Methodology: https://510kreport.com/methodology