510(k) · Cleared
Recalled · Class II · 2019Ana-Screen with MDSS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · LKJ Antinuclear Antibody, Antigen, Control
Cleared on Jul 9, 2012 as substantially equivalent to K043341 (Bio-Rad Laboratories, Inc., 2005) after a 216-day review. Its family tree reaches back 2 generations to 1995. It has been recalled once.
- Decided
- Jul 9, 2012
- Review
- 216 days
- Class
- Class II
- Product code
- LKJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941596 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LKJ device
- #1 K210902 EliA Ro52, EliA Ro60score 4.0 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K043341 | Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200…Summary page 2…creen with MDSS Regulation Number 862.3100 Product Code NVI Legally Marketed Predicate Device BioPlex® 2200 ANA Screen with MDSS, k043341 Intended Use The BioPlex® 2200 ANA Screen is intended for the qualitative screening of specific antinuclear antibodies (ANA), th… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2019 | Class II | Z-0082-2022 | Process control | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K043341.
How does its category compare?
All LKJ devicesLKJ Antinuclear Antibody, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LKJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LKJ
Too few LKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LKJ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKJ
2in 2018
MAUDE reports naming product code LKJ, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 7 | 2 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (195 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113610: Ana-Screen with MDSS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113610
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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