510(k) · Cleared
ClearedRhigene Hep-Ana Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corgenix, Inc. · DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Cleared on Nov 19, 2004 as substantially equivalent to K872845 (Bion Ent., Ltd., 1987) after a 51-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Nov 19, 2004
- Review
- 51 days
- Class
- Class II
- Product code
- DHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K872845 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK872845 Bion Antinuclear Antibody (Ana)Test Kit/Contr SerumBion Ent., Ltd. · 1987
- This deviceK042680 Rhigene Hep-Ana Test SystemCorgenix, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872845 | Bion Antinuclear Antibody (Ana)Test Kit/Contr Serum | Bion Ent., Ltd. | 1987 | — |
| 0 (this device) | K042680 | Rhigene Hep-Ana Test System | Corgenix, Inc. | 2004 | — |
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 DHN? 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 |
|---|---|---|---|
| * | K872845 | Bion Antinuclear Antibody (Ana)Test Kit/Contr SerumSummary page 1…redicate device and a substantial equivalence claim made. The predicate device is RhiGenc Titer-Fluor ANA Test System (manufactured by BION ENTERPRISES, Des Plaines, IL, K872845), currently marketed by RhiGene, Inc. Des Plaines, IL. The RihiGene HEP-ANA Test System is an indirect fluorescent antibody assa… | 1987 |
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.
- 1 other device also cites its predicate K872845.
How does its category compare?
All DHN devicesDHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DHN
Too few DHN 510(k)s in any year since 2007 to give a median.
Recalls per year · DHN
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHN
No MAUDE report names DHN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 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 HEP-ANA Test System is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies in human serum. The HEP-ANA Test System is intended for use as an aid in the diagnosis of certain autoimmune diseases.
The HEP-ANA Test System is intended to be used by clinical (hospital and reference) laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042680 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042680: Rhigene Hep-Ana Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042680
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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