# K041658: Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Dec 20, 2004 after 185 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: 1 generation back to K922830 (1992). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011244: Zeus Scientific, Inc. Athena Multi-Lyte Ana Test System, Zeus Scientific, Inc. (2001)
- K970227: Immulite 2000 Automated Immunoassay Analyzer, Dpc Cirrus (1997) Summary page 2.
- K954723: Enzyme Immunoassay Ana Screening Test Kit, Helix Diagnostics, Inc. (1995) Summary page 2.
- K922830: Quanta Lite SS-a Elisa, Inova Diagnostics, Inc. (1992) Summary page 2.
- K932419: Anti-SS-B/LA Antibody Test, Helix Diagnostics, Inc. (1993) Summary page 2.
- K922831: Quanta Lite SM Elisa, Inova Diagnostics, Inc. (1992) Summary page 2.
- K922833: Quanta Lite RNP Elisa, Inova Diagnostics, Inc. (1992) Summary page 2.
- K993589: Varelisa RNP Antibodies, Pharmacia & Upjohn Co. (1999). Our OCR of the scanned summary read K993580, FDA’s number for Specialty 55 (Methafilcon a) Soft (Hydrophilic) Contact… (Specialty Ultravision, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Varelisa® RNP Antibodies”.
- K981237: Quanta Lite Ribosome P Elisa, Inova Diagnostics, Inc. (1998) Summary page 2.
- K982603: Quanta Lite Chromatin Elisa, Inova Diagnostics, Inc. (1998) Summary page 2.
- K950031: Varelisa Dsdna Antibodies (Farr Version), Elias U.S.A., Inc. (1995) Summary page 2.
- K000489: Enzyme Immunoassay Anti-Centromere Antibody Test, Helix Diagnostics, Inc. (2000) Summary page 2.
- K951798: Enzyme Immunoassay Anti-Sci-70 Antibody Test Kit, Helix Diagnostics, Inc. (1995) Summary page 2.
- K951850: Enzyme Immunoassay Anti-JO-1 Antibody Test Kit, Helix Diagnostics, Inc. (1995) Summary page 2.

## Most influential descendants
- K083080: Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform (2009), 0 descendants of its own

## 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 Bio-Plex 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, Sm/RNP, RNP, Scl-70, Jo-'t and Centromere B,) in human serum and/or EDTA or heparinized plasma. The ANA Screen is intended for use with the Bio-Rad BioPlex 2200 System. Uses: The test system 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 rheumatic diseases (Systemic Lupus Erythematosus [SLE], Mixed Connective Tissue Disease [MCTD], Undifferentiated Connective Tissue Disease [UCTD], Sjigren'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.

Source page: https://510kreport.com/device/K041658
Methodology: https://510kreport.com/methodology