510(k) · Cleared
ClearedEna Igg Beadchip Test System, Array Imaging System, Models 800-00025, Ais 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioarray Solutions, Ltd. · LLL Extractable Antinuclear Antibody, Antigen And Control
Cleared on May 31, 2005 as substantially equivalent to K964787 (Mardx Diagnostics, Inc., 1997) after a 204-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- May 31, 2005
- Review
- 204 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964787 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964787 Mardx Ena Igg Immunostripe Test System / Mardx Ena Igg Marstripe…Mardx Diagnostics, Inc. · 1997
- This deviceK043067 Ena Igg Beadchip Test System, Array Imaging System, Models…Bioarray Solutions, Ltd. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964787 | Mardx Ena Igg Immunostripe Test System / Mardx Ena Igg Marstripe Test System | Mardx Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K043067 | Ena Igg Beadchip Test System, Array Imaging System, Models 800-00025, Ais 400 | Bioarray Solutions, Ltd. | 2005 | — |
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 LLL? 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 LLL device
- #1 K253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/Lascore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K964787 | Mardx Ena Igg Immunostripe Test System / Mardx Ena Igg Marstripe Test SystemSummary page 1…t System Distributed by SLR Research Corporation Cleared on April 8, 1995 under document number K964787 by Mardx Diagnostics. INTENDED USE The BioArray Solutions ENA IgG BeadChip TM Test System… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LLL devicesLLL Extractable Antinuclear Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLL
265in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLL
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLL
1in 2011
MAUDE reports naming product code LLL, 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 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 265 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The BioArray Solutions ENA IgG BeadChip Tm Test System is intended for use in testing human serum for the presence of human IgG class antibodies to six extractable nuclear antigens, SSA, SSB, Sm, Sm/RNP, Scl-70, and Jo-l. The presence of these autoantibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus, Sj6gren's syndrome, scleroderma and myositis. This ENA IgG BeadChip is for use with Array Imaging System 400 (AIS400). This test is for in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043067 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043067: Ena Igg Beadchip Test System, Array Imaging System, Models 800-00025, Ais 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043067
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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