510(k) · Cleared
Recalled · Class II · 2019Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · LKJ Antinuclear Antibody, Antigen, Control
Cleared on Dec 20, 2004 as substantially equivalent to K011244 (Zeus Scientific, Inc., 2001) and 13 other predicates after a 185-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 20, 2004
- Review
- 185 days
- Class
- Class II
- Product code
- LKJ
- Recalls
- 1
- Predicates
- 14
Its longest line of descent runs back 1 generation to K922830 (1992). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK922830 Quanta Lite SS-a ElisaInova Diagnostics, Inc. · 1992
- This deviceK041658 Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK083080 Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics…Sqi Diagnostics Systems · 2009
Most influential descendants
Showing 1 of 1 · See all- K083080Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics PlatformSqi Diagnostics Systems · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922830 | Quanta Lite SS-a Elisa | Inova Diagnostics, Inc. | 1992 | — |
| 0 (this device) | K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System… | Bio-Rad Laboratories, Inc. | 2004 | — |
| +1 | K083080 | Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform | Sqi Diagnostics Systems | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 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? (14)
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 |
|---|---|---|---|
| * | K011244 | Zeus Scientific, Inc. Athena Multi-Lyte Ana Test System | 2001 |
| * | K970227 | Immulite 2000 Automated Immunoassay AnalyzerSummary page 2…Code | Date BioPlex 2200 ANA Screen | Zeus Athena Multi-Lyte ANA Test System KO11244 | LKIJ 12/10/2001 on the BioPlex 2200 Diagnostic Products Corporation (DPC) Immulite K970227 | JJE 4/8/1997 System 2000 Automated Immunoassay Analyzer Assay BioPlex2200 ANA Screen | Comparative FDA Cleared Device 510(k) Pr… | 1997 |
| * | K954723 | Enzyme Immunoassay Ana Screening Test KitSummary page 2…| Comparative FDA Cleared Device 510(k) Product | Decision Number | Code Date ANA Screen (based on — . . results of all analytes listed | b'0-Rad (Helix) Autoimmune EIA 954723 | LKI | 12/15/1995 ANA Screening Test below) BioPlex2200 ANA Comparative FDA Cleared 510(k) Product | Decision Screen Analyte PRE… | 1995 |
| * | K922830 | Quanta Lite SS-a ElisaSummary page 2…0 ANA Comparative FDA Cleared 510(k) Product | Decision Screen Analyte PREDICATE DEVICE Number | Code Date Lol 3eh (SS;A 60and [y \a Diagnostics, Inc. QUANTA Lite™ SSA | 922830 | LLL | 9/18/1992 Bio-Rad (Helix) Autoimmune EIA 2. SSB SS-B / La Test 932419 LLL 8/5/1993 3. Sm Inova Diagnostics, Inc. QUANTA L… | 1992 |
| * | K932419 | Anti-SS-B/LA Antibody TestSummary page 2…TE DEVICE Number | Code Date Lol 3eh (SS;A 60and [y \a Diagnostics, Inc. QUANTA Lite™ SSA | 922830 | LLL | 9/18/1992 Bio-Rad (Helix) Autoimmune EIA 2. SSB SS-B / La Test 932419 LLL 8/5/1993 3. Sm Inova Diagnostics, Inc. QUANTA Lite™ Sm 922831 LLL 9/18/1992 Inova Diagnostics, Inc. QUANTA Lite™ RNP 4, SmRNP… | 1993 |
| * | K922831 | Quanta Lite SM ElisaSummary page 2…, Inc. QUANTA Lite™ SSA | 922830 | LLL | 9/18/1992 Bio-Rad (Helix) Autoimmune EIA 2. SSB SS-B / La Test 932419 LLL 8/5/1993 3. Sm Inova Diagnostics, Inc. QUANTA Lite™ Sm 922831 LLL 9/18/1992 Inova Diagnostics, Inc. QUANTA Lite™ RNP 4, SmRNP (Sm/RNP) 922833 LLL 9/18/1992 SN gNP 68and | pprmacia Varelisa® R… | 1992 |
| * | K922833 | Quanta Lite RNP ElisaSummary page 2…A 2. SSB SS-B / La Test 932419 LLL 8/5/1993 3. Sm Inova Diagnostics, Inc. QUANTA Lite™ Sm 922831 LLL 9/18/1992 Inova Diagnostics, Inc. QUANTA Lite™ RNP 4, SmRNP (Sm/RNP) 922833 LLL 9/18/1992 SN gNP 68and | pprmacia Varelisa® RNP Antibodies 993580 | LKO | 11/26/1999 . . Inova Diagnostics, Inc. QUANTA 6. Ri… | 1992 |
| * | K993589 | Varelisa RNP Antibodies 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”. | 1999 |
| * | K981237 | Quanta Lite Ribosome P ElisaSummary page 2…) 922833 LLL 9/18/1992 SN gNP 68and | pprmacia Varelisa® RNP Antibodies 993580 | LKO | 11/26/1999 . . Inova Diagnostics, Inc. QUANTA 6. Ribosomal Protein Lite™Ribosome P 981237 MQA 6/5/1998 . Inova Diagnostics, Inc. QUANTA Lite™ 7. Chromatin Chromatin ELISA 982603 LLL 10/7/1998 3. dsDNA ' thlrmuua Varelis… | 1998 |
| * | K982603 | Quanta Lite Chromatin ElisaSummary page 2…1/26/1999 . . Inova Diagnostics, Inc. QUANTA 6. Ribosomal Protein Lite™Ribosome P 981237 MQA 6/5/1998 . Inova Diagnostics, Inc. QUANTA Lite™ 7. Chromatin Chromatin ELISA 982603 LLL 10/7/1998 3. dsDNA ' thlrmuua Varelisa® ds-DNA ANTIBODY EIA 950031 LRM 3/10/1995 (quant. / semi-quant.) | Kit 9. Centromere B… | 1998 |
| * | K950031 | Varelisa Dsdna Antibodies (Farr Version)Summary page 2…Ribosome P 981237 MQA 6/5/1998 . Inova Diagnostics, Inc. QUANTA Lite™ 7. Chromatin Chromatin ELISA 982603 LLL 10/7/1998 3. dsDNA ' thlrmuua Varelisa® ds-DNA ANTIBODY EIA 950031 LRM 3/10/1995 (quant. / semi-quant.) | Kit 9. Centromere BLOTRad (Helix) Autoimmune EIA 000489 LLL 4/15/2000 Anti-Centromere Test… | 1995 |
| * | K000489 | Enzyme Immunoassay Anti-Centromere Antibody TestSummary page 2…ISA 982603 LLL 10/7/1998 3. dsDNA ' thlrmuua Varelisa® ds-DNA ANTIBODY EIA 950031 LRM 3/10/1995 (quant. / semi-quant.) | Kit 9. Centromere BLOTRad (Helix) Autoimmune EIA 000489 LLL 4/15/2000 Anti-Centromere Test i Bio-Rad (Helix) Autoimmune EIA 10. | Scl-70 Anti-Scl-70 Test 951798 LIM 7/17/1995 Bio-Rad (H… | 2000 |
| * | K951798 | Enzyme Immunoassay Anti-Sci-70 Antibody Test KitSummary page 2…semi-quant.) | Kit 9. Centromere BLOTRad (Helix) Autoimmune EIA 000489 LLL 4/15/2000 Anti-Centromere Test i Bio-Rad (Helix) Autoimmune EIA 10. | Scl-70 Anti-Scl-70 Test 951798 LIM 7/17/1995 Bio-Rad (Helix) Autoimmune EIA 11. | Jo-1 Anti-Jo-1 Test 951850 LIM 7/18/1995 BioPlex 2200 ANA Screen 510(k) Summar… | 1995 |
| * | K951850 | Enzyme Immunoassay Anti-JO-1 Antibody Test KitSummary page 2…15/2000 Anti-Centromere Test i Bio-Rad (Helix) Autoimmune EIA 10. | Scl-70 Anti-Scl-70 Test 951798 LIM 7/17/1995 Bio-Rad (Helix) Autoimmune EIA 11. | Jo-1 Anti-Jo-1 Test 951850 LIM 7/18/1995 BioPlex 2200 ANA Screen 510(k) Summary (revised 12-13-04) Page 2 of 19 DEVICE DESCRIPTION The ANA… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083080 | Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform | 2009 | 0 |
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?
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K083080 (Sqi Diagnostics Systems, 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LKJ devicesLKJ Antinuclear Antibody, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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…
Read the full statement (137 words)
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.
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/K041658 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041658: Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041658
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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