510(k) · Cleared
ClearedHep-2000 Fluorescent Ana-RO Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immuno Concepts, Inc. · DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Cleared on Feb 24, 1998 as substantially equivalent to K955603 (Immuno Concepts, Inc., 1996) after a 263-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 24, 1998
- Review
- 263 days
- Class
- Class II
- Product code
- DHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935129 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK935129 Relisa Ena Antibody Screening Test SystemImmuno Concepts, Inc. · 1994 · Recalled
- 1 generation backK955603 Relsia SS-a/RO & SS/B LA Antibody Test SystemImmuno Concepts, Inc. · 1996
- This deviceK972145 Hep-2000 Fluorescent Ana-RO Test SystemImmuno Concepts, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK131791 Ifa 40: Hep-20-10Euroimmun US · 2014
- Descendant · cites it directly · 0 of its ownK060431 Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935129 | Relisa Ena Antibody Screening Test System | Immuno Concepts, Inc. | 1994 | 1 |
| −1 | K955603 | Relsia SS-a/RO & SS/B LA Antibody Test System | Immuno Concepts, Inc. | 1996 | — |
| 0 (this device) | K972145 | Hep-2000 Fluorescent Ana-RO Test System | Immuno Concepts, Inc. | 1998 | — |
| +1 | K131791 | Ifa 40: Hep-20-10 | Euroimmun US | 2014 | — |
| +1 | K060431 | Anti Rna Polymerase Iii Elisa Kit, Model 7805 | Mbl International Corporation | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
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 |
|---|---|---|---|
| * | K955603 | Relsia SS-a/RO & SS/B LA Antibody Test SystemSummary page 1…on Name - Antinuclear Antibody (21 CFR 866.5100) Legally marketed device with which this device has been shown to be equivalent: RELISA® SS-A/SS-B Antibody Test System, K955603 Description: This is an indirect fluorescent antibody test for the semi-quantitative detection of antinuclear antibody in human… | 1996 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K131791 (Euroimmun US, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K955603.
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?
This is an indirect fluorescent antibody test for the semi-quantitative detection of antinuclear antibodies in human serum, with specific identification of autoantibodies to the SS-A/Ro antigen. This test system is to be used as an aid in the detection of antibodies associated with system 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/K972145 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972145: Hep-2000 Fluorescent Ana-RO Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972145
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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