510(k) · Cleared
Recalled · 2007Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · NVI Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
Cleared on Oct 27, 2005 as substantially equivalent to K941596 (Bio-Rad, 1995) after a 328-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 27, 2005
- Review
- 328 days
- Class
- Class II
- Product code
- NVI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941596 (1995). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK941596 Remedi HS Drug Profiling SystemBio-Rad · 1995
- This deviceK043341 Bioplex 2200 Ana Screen with Medical Decision Support Software for…Bio-Rad Laboratories, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK080896 Pathwork Diagnostics Tissue of Origin TestPathwork Diagnostics, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK092967 Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-FfpePathwork Diagnostics · 2010
- Descendant · 3 generations on · 1 of its ownK120489 Tissue of Origin Test Kit FfpePathwork Diagnostics, Inc. · 2012
- Descendant · 4 generations on · 0 of its ownK173839 Tissue of Origin Test Kit-FFPECancer Genetics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK113610 Ana-Screen with MDSSBio-Rad Laboratories · 2012 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K080896Pathwork Diagnostics Tissue of Origin TestPathwork Diagnostics, Inc. · 2008 · cites it directly3descendants
- K092967Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-FfpePathwork Diagnostics · 2010 · 2 generations on2descendants
- K120489Tissue of Origin Test Kit FfpePathwork Diagnostics, Inc. · 2012 · 3 generations on1descendant
- K173839Tissue of Origin Test Kit-FFPECancer Genetics, Inc. · 2018 · 4 generations on0descendants
- K113610Ana-Screen with MDSSBio-Rad Laboratories · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941596 | Remedi HS Drug Profiling System | Bio-Rad | 1995 | — |
| 0 (this device) | K043341 | Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with… | Bio-Rad Laboratories, Inc. | 2005 | — |
| +1 | K080896 | Pathwork Diagnostics Tissue of Origin Test | Pathwork Diagnostics, Inc. | 2008 | — |
| +2 | K092967 | Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-Ffpe | Pathwork Diagnostics | 2010 | — |
| +3 | K120489 | Tissue of Origin Test Kit Ffpe | Pathwork Diagnostics, Inc. | 2012 | — |
| +4 | K173839 | Tissue of Origin Test Kit-FFPE | Cancer Genetics, Inc. | 2018 | — |
| +1 | K113610 | Ana-Screen with MDSS | Bio-Rad Laboratories | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NVI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941596 | Remedi HS Drug Profiling SystemSummary page 2…Number Code Date Medical Decision Support Renedi HIS l)rtt. Pro System K941596 DNI March 27. 1995 Software (MDSS) 4.0 DEVICE DESCRIPTION Note: The Ibllowing product description is limited to… | 1995 |
| † | K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex… | 2004 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2007 | Not classified | Z-0575-2008 | Software design | 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 those printed on the Value Assignment… |
| Nov 13, 2007 | Not classified | Z-1159-2008 | Nonconforming Material/Component | False negative results due to reagent packs exhibiting low signal. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K080896 (Pathwork Diagnostics, Inc., 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NVI devicesNVI Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NVI
FDA has decided no NVI device since 2007.
Median 510(k) review, days · NVI
Too few NVI 510(k)s in any year since 2007 to give a median.
Recalls per year · NVI
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NVI
1in 2019
MAUDE reports naming product code NVI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (195 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K043341 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043341: Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043341
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026