510(k) · Cleared
ClearedHemagen Ena Dsdna Kit (Eia Method)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemagen Diagnostics, Inc. · DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Cleared on Dec 5, 1996 as substantially equivalent to K771376 (Electro-Nucleonics Laboratories, Inc., 1977) after a 175-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- Dec 5, 1996
- Review
- 175 days
- Class
- Class II
- Product code
- DHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K771376 (1977). No later device cites it as a predicate yet.
- Root · 1 generation backK771376 Ifa Anti-NdnaElectro-Nucleonics Laboratories, Inc. · 1977
- This deviceK962276 Hemagen Ena Dsdna Kit (Eia Method)Hemagen Diagnostics, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771376 | Ifa Anti-Ndna | Electro-Nucleonics Laboratories, Inc. | 1977 | — |
| 0 (this device) | K962276 | Hemagen Ena Dsdna Kit (Eia Method) | Hemagen Diagnostics, Inc. | 1996 | — |
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 |
|---|---|---|---|
| * | K771376 | Ifa Anti-NdnaSummary page 1…hod) Common Name: Anti-DNA Classification Name: Anti-DNA Antibody, Antigen and Control 3. Predicate Device Hemagen VIRGO ® Anti-nDNA I1gG IFA Kit {Reference 510 (k) No. K 771376A} 3. Description of Device An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measureme… | 1977 |
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 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?
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of circulating antibodies to native DNA. These autoantibodies are often associated with systemic lupus erythematosus (SLE) and give positive results in screening tests for antinuclear antibodies.
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/K962276 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962276: Hemagen Ena Dsdna Kit (Eia Method).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962276
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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