510(k) · Cleared
Recalled · 2010Quantafluor Fluorescent Test Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kallestad Laboratories, Inc. · DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Cleared on Jan 18, 1982 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 18, 1982
- Review
- 21 days
- Class
- Class II
- Product code
- DHN
- Recalls
- 2
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK813592 Quantafluor Fluorescent Test ReagentsKallestad Laboratories, Inc. · 1982
- Descendant · cites it directly · 2 of its ownK984397 Liquichek Ana Control, Centromere Pattern, Model 203Bio-Rad · 1998
- Descendant · 2 generations on · 0 of its ownK024230 Liquichek Ana Control Set, Positive: Homogeneous, Speckled…Bio-Rad · 2003
- Descendant · 2 generations on · 0 of its ownK024222 Liquichek Ana Control Centromere Pattern, Positive, Catalog #112Bio-Rad · 2003
- Descendant · cites it directly · 0 of its ownK984396 Liquichek Anti-Dsdna Control, Model 213Bio-Rad · 1998
- Descendant · cites it directly · 0 of its ownK984399 Liquichek Ana Control, Nucleolar Pattern, Model 204Bio-Rad · 1998
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K984397Liquichek Ana Control, Centromere Pattern, Model 203Bio-Rad · 1998 · cites it directly2descendants
- K024230Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and Nucleolar…Bio-Rad · 2003 · 2 generations on0descendants
- K024222Liquichek Ana Control Centromere Pattern, Positive, Catalog #112Bio-Rad · 2003 · 2 generations on0descendants
- K984396Liquichek Anti-Dsdna Control, Model 213Bio-Rad · 1998 · cites it directly0descendants
- K984399Liquichek Ana Control, Nucleolar Pattern, Model 204Bio-Rad · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K813592 | Quantafluor Fluorescent Test Reagents | Kallestad Laboratories, Inc. | 1982 | — |
| +1 | K984397 | Liquichek Ana Control, Centromere Pattern, Model 203 | Bio-Rad | 1998 | — |
| +2 | K024230 | Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and… | Bio-Rad | 2003 | — |
| +2 | K024222 | Liquichek Ana Control Centromere Pattern, Positive, Catalog #112 | Bio-Rad | 2003 | — |
| +1 | K984396 | Liquichek Anti-Dsdna Control, Model 213 | Bio-Rad | 1998 | — |
| +1 | K984399 | Liquichek Ana Control, Nucleolar Pattern, Model 204 | Bio-Rad | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 4 | 0 |
| 2003 | 2 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2010 | Not classified | Z-3051-2011 | Employee error | KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides. |
| Jul 29, 2008 | Not classified | Z-2429-2008 | Employee error | The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K984397 (Bio-Rad, 1998) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K813592 · printed Nov 5, 2026
Cite this page
510(k) Report. “K813592: Quantafluor Fluorescent Test Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K813592
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026