510(k) · Cleared
ClearedEnzyme Immunoassay Anti-Sci-70 Antibody Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helix Diagnostics, Inc. · LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Cleared on Jul 17, 1995 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jul 17, 1995
- Review
- 90 days
- Class
- Class II
- Product code
- LJM
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK951798 Enzyme Immunoassay Anti-Sci-70 Antibody Test KitHelix Diagnostics, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK041658 Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK083080 Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics…Sqi Diagnostics Systems · 2009
Most influential descendants
Showing 2 of 2 · See all- K041658Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…Bio-Rad Laboratories, Inc. · 2004 · cites it directly1descendant
- K083080Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics PlatformSqi Diagnostics Systems · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951798 | Enzyme Immunoassay Anti-Sci-70 Antibody Test Kit | Helix Diagnostics, Inc. | 1995 | — |
| +1 | K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System… | Bio-Rad Laboratories, Inc. | 2004 | 1 |
| +2 | K083080 | Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform | Sqi Diagnostics Systems | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex… | 2004 | 1 |
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?
- Of its descendants, K041658 (Bio-Rad Laboratories, Inc., 2004) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K951798 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951798: Enzyme Immunoassay Anti-Sci-70 Antibody Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951798
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026