# K113610: Ana-Screen with MDSS

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad Laboratories
- Decided: Jul 9, 2012 after 216 days
- Product code: LKJ (Antinuclear Antibody, Antigen, 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: 2 generations back to K941596 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043341: Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System, Bio-Rad Laboratories, Inc. (2005) Summary page 2.

## Recalls of this device
- Nov 1, 2019 · Class II · Z-0082-2022: A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.

## Indications for use
The BioPlex® 2200 ANA Screen is intended for the qualitative screening of specific antinuclear antibodies (ANA), the quantitative detection of antibody to dsDNA, and the semi-quantitative detection of ten (10) separate antibody assays (Chromatin, Ribosomal Protein, SS-A, SS-B, Sm, SmRNP, RNP, Scl-70, Jo-i, and Centromere B) in human serum and/or EDTA or heparinized plasma. The ANA Screen is used to screen serum or plasma (EDTA, heparin) samples and detects the presence of antinuclear antibodies as an aid in the diagnosis of systemic autoimmune diseases (Systemic Ltipus Erythematosus [SLE], Mixed Connective Tissue Disease [MCTD], Undifferentiated Connective Tissue-Disease [UCTD], Sjdgren's Syndrome [SS], Scieroderma [Systemic Sclerosis], Dermatomyositis, Polymyositis, Rheumatoid Arthritis [RA], CREST Syndrome, and Raynaud's Phenomenon) in conjunction with clinical findings and other laboratory tests. The ANA Screen is intended for use, with the Bio-Rad BioPlex 2200 System. The BioPlex 2200 Medical Decision Support Software (MDSS), used in conjunction -with the ANA Screen, is an optional laboratory tool that associates patient antibody results from the AINA Screeni with predefmied MLDSS profiles that have been correlated with the following systemic autoimmune diseases: Systemic Lupus Erythematosus (SLE), Mixed Connective Tissue Disease (MCTD), Sje~gren's Syndrome (SS), Sclerodenna (Systemic Sclerosis) and Polymyositis.

Source page: https://510kreport.com/device/K113610
Methodology: https://510kreport.com/methodology