# K043341: Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Oct 27, 2005 after 328 days
- Product code: NVI (Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941596 (1995). 1 ancestor in all.
5 later devices descend from it; 2 cite 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)
- K941596: Remedi HS Drug Profiling System, Bio-Rad (1995) Summary page 2.

## Most influential descendants
- K080896: Pathwork Diagnostics Tissue of Origin Test (2008), 3 descendants of its own
- K092967: Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-Ffpe (2010), 2 descendants of its own
- K120489: Tissue of Origin Test Kit Ffpe (2012), 1 descendant of its own
- K173839: Tissue of Origin Test Kit-FFPE (2018), 0 descendants of its own
- K113610: Ana-Screen with MDSS (2012), 0 descendants of its own

## Recalls of this device
- Nov 13, 2007 · Not classified · Z-0575-2008: Incorrect values: An error was found in the BioPlex 2200 Software, Version 2.0 that results in assignment values being utilized for the BioPlex assay Calibrator Set that may be slightly different from
- Nov 13, 2007 · Not classified · Z-1159-2008: False negative results due to reagent packs exhibiting low signal.

## Indications for use
Tihe BioPlexTM 2200 ANA Screen is intended for the qualitative screening of specific antinuclear antibodies (ANA), the quantitative dejection of antibody to dsDNA, and the semi-quantitative detection often (10) separate antibody assays (Chromatin, Ribosomal Protein, SS-A, SS-B, Sin, SmRNP, RNP, Scl-70, Jo-], 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 detect the presence of antinuclear antibodies as an aid in the diagnosis of systemic autoimmune diseases (Systemic Lupus Erythematosus [SLE], Mixed Connective Tissue Disease [MCTD], Undifferentiated Connective Tissue Disease [UCTD], Sjögren's Syndrome [SS], Scleroderma [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 ANA Screen with predefined MDSS profiles that have been correlated with the following systemic autoimmune diseases: Systemic Lupus Erythematosus (SLE), Mixed Connective Tissue Disease (MCTD), Sjögren's Syndrome (SS), Scleroderma (Systemic Sclerosis) and Polymyositis.

Source page: https://510kreport.com/device/K043341
Methodology: https://510kreport.com/methodology