510(k) · Cleared
ClearedRelisa Ana Screening Test System, Model 7096-11
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immuno Concepts, Inc. · LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Cleared on Jul 23, 1999 as substantially equivalent to K954723 (Helix Diagnostics, Inc., 1995) after a 36-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jul 23, 1999
- Review
- 36 days
- Class
- Class II
- Product code
- LJM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954723 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK954723 Enzyme Immunoassay Ana Screening Test KitHelix Diagnostics, Inc. · 1995 · Recalled
- This deviceK992041 Relisa Ana Screening Test System, Model 7096-11Immuno Concepts, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954723 | Enzyme Immunoassay Ana Screening Test Kit | Helix Diagnostics, Inc. | 1995 | 6 |
| 0 (this device) | K992041 | Relisa Ana Screening Test System, Model 7096-11 | Immuno Concepts, Inc. | 1999 | — |
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 LJM? 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 |
|---|---|---|---|
| * | K954723 | Enzyme Immunoassay Ana Screening Test KitSummary page 1…ith which this device has been shown to be equivalent: Enzyme Immunoassay Antinuclear Antibody Screening Test Kit manufactured by Helix Diagnostics, West Sacramento, CA, K954723. Description: This is an enzyme immunoassay for the detection of antinuclear antibodies in human serum. Intended Use: This is… | 1995 |
| † | K944096 | Hep-2000 Fluorescent Ana-RO Test System | 1994 |
| † | K972145 | Hep-2000 Fluorescent Ana-RO Test System | 1998 |
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 a recall.
- 10 other devices also cite its predicate K954723.
How does its category compare?
All LJM devicesLJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJM
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · LJM
265in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJM
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJM
No MAUDE report names LJM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 3 | 265 | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 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?
This is an enzyme immunoassay test system for the detection of antinuclear antibodies in human serum. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.
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/K992041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992041: Relisa Ana Screening Test System, Model 7096-11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992041
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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