510(k) · Cleared
ClearedHep-2000 Colorzyme Ana-RO Test System, Model 4200-RO
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 Dec 18, 1998 as substantially equivalent to K955603 (Immuno Concepts, Inc., 1996) after a 44-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Dec 18, 1998
- Review
- 44 days
- Class
- Class II
- Product code
- DHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935129 (1994). No later device cites it as a predicate yet.
- 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 deviceK983924 Hep-2000 Colorzyme Ana-RO Test System, Model 4200-ROImmuno Concepts, Inc. · 1998
View 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) | K983924 | Hep-2000 Colorzyme Ana-RO Test System, Model 4200-RO | Immuno Concepts, Inc. | 1998 | — |
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 immunoenzyme antibody test for the semi-quantitative detection of antinuclear antibody in huma… | 1996 |
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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 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 immunoenzyme 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 systemic 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/K983924 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983924: Hep-2000 Colorzyme Ana-RO Test System, Model 4200-RO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983924
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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