510(k) · Cleared
Recalled · 2010Enzyme Immunoassay Ana Screening Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helix Diagnostics, Inc. · LKJ Antinuclear Antibody, Antigen, Control
Cleared on Dec 15, 1995 after a 63-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 17 later devices descend from it. It has been recalled 6 times.
- Decided
- Dec 15, 1995
- Review
- 63 days
- Class
- Class II
- Product code
- LKJ
- Recalls
- 6
- Predicates
- 0
17 later devices descend from it, 11 citing it directly.
- This deviceK954723 Enzyme Immunoassay Ana Screening 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 · cites it directly · 1 of its ownK984476 Liquichek Anti-RNP Control, Eia, Model 207Bio-Rad · 1998
- Descendant · cites it directly · 1 of its ownK984479 Liquichek Anti-SM Control, Eia, Model 208Bio-Rad · 1998
- Descendant · cites it directly · 1 of its ownK984470 Liquichek Anti-SS-a Control, Eia, Model 209Bio-Rad · 1998
- Descendant · cites it directly · 1 of its ownK984475 Liquichek Anti-SCL-70 Control, Eia, Model 212Bio-Rad · 1998
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K041658Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…Bio-Rad Laboratories, Inc. · 2004 · cites it directly1descendant
- K984476Liquichek Anti-RNP Control, Eia, Model 207Bio-Rad · 1998 · cites it directly1descendant
- K984479Liquichek Anti-SM Control, Eia, Model 208Bio-Rad · 1998 · cites it directly1descendant
- K984470Liquichek Anti-SS-a Control, Eia, Model 209Bio-Rad · 1998 · cites it directly1descendant
- K984475Liquichek Anti-SCL-70 Control, Eia, Model 212Bio-Rad · 1998 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954723 | Enzyme Immunoassay Ana Screening 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 |
| +1 | K984476 | Liquichek Anti-RNP Control, Eia, Model 207 | Bio-Rad | 1998 | — |
| +1 | K984479 | Liquichek Anti-SM Control, Eia, Model 208 | Bio-Rad | 1998 | — |
| +1 | K984470 | Liquichek Anti-SS-a Control, Eia, Model 209 | Bio-Rad | 1998 | — |
| +1 | K984475 | Liquichek Anti-SCL-70 Control, Eia, Model 212 | Bio-Rad | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 8 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (17)
See all 1711 later devices cite 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 |
| K984476 | Liquichek Anti-RNP Control, Eia, Model 207 | 1998 | 1 |
| K984479 | Liquichek Anti-SM Control, Eia, Model 208 | 1998 | 1 |
| K984470 | Liquichek Anti-SS-a Control, Eia, Model 209 | 1998 | 1 |
| K984475 | Liquichek Anti-SCL-70 Control, Eia, Model 212 | 1998 | 1 |
| K984478 | Liquichek Anti-SS-B Control, Eia, Model 210 | 1998 | 1 |
| K021257 | Ana Line Blot, Catalog Number: Kalabi (20 Tests) | 2002 | 0 |
| K992041 | Relisa Ana Screening Test System, Model 7096-11 | 1999 | 0 |
| K984462 | Liquichek Ena Control, Eia Screen, Model NO. 206 | 1998 | 0 |
| K984473 | Liquichek Ana Control, Eia Screen, Model 205 | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2010 | Not classified | Z-0612-2011 | Labeling mix-ups | Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass.. |
| Mar 1, 2010 | Not classified | Z-0539-2011 | Other | The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading. |
| Mar 1, 2010 | Not classified | Z-0540-2011 | Other | The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading. |
| Mar 1, 2010 | Not classified | Z-1478-2011 | Nonconforming Material/Component | Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit. |
| Mar 1, 2010 | Not classified | Z-1479-2011 | Nonconforming Material/Component | The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability. |
| Feb 24, 2010 | Not classified | Z-0613-2011 | Other | False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. False positive ANA values could result… |
The 5 latest of 6 recalls; the web page lists all.
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 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 | — |
https://510kreport.com/device/K954723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954723: Enzyme Immunoassay Ana Screening Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954723
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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