510(k) · Cleared
Recalled · 2008Kallestad Florescent Ana/Ama/Asma Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kallestad Laboratories, Inc. · DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Cleared on Feb 22, 1980 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled once.
- Decided
- Feb 22, 1980
- Review
- 66 days
- Class
- Class II
- Product code
- DBL
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 7 citing it directly.
- This deviceK792610 Kallestad Florescent Ana/Ama/Asma TestKallestad Laboratories, Inc. · 1980
- Descendant · cites it directly · 0 of its ownK024230 Liquichek Ana Control Set, Positive: Homogeneous, Speckled…Bio-Rad · 2003
- Descendant · cites it directly · 0 of its ownK024224 Liquichek Anti-Smooth Muscle Control, Positive, Catalog #129Bio-Rad · 2003
- Descendant · cites it directly · 0 of its ownK024227 Liquichek Anti-Mitochondrial Control, Positive, Catalog #127Bio-Rad · 2003
- Descendant · cites it directly · 0 of its ownK024217 Liquichek Ana Control, Speckled Pattern, Positive, Catalog #108Bio-Rad · 2003
- Descendant · cites it directly · 0 of its ownK024221 Liquichek Ana Control Homogeneous Pattern Control, Posotive, Catalog…Bio-Rad · 2003
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K024230Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and Nucleolar…Bio-Rad · 2003 · cites it directly0descendants
- K024224Liquichek Anti-Smooth Muscle Control, Positive, Catalog #129Bio-Rad · 2003 · cites it directly0descendants
- K024227Liquichek Anti-Mitochondrial Control, Positive, Catalog #127Bio-Rad · 2003 · cites it directly0descendants
- K024217Liquichek Ana Control, Speckled Pattern, Positive, Catalog #108Bio-Rad · 2003 · cites it directly0descendants
- K024221Liquichek Ana Control Homogeneous Pattern Control, Posotive, Catalog #118Bio-Rad · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K792610 | Kallestad Florescent Ana/Ama/Asma Test | Kallestad Laboratories, Inc. | 1980 | — |
| +1 | K024230 | Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and… | Bio-Rad | 2003 | — |
| +1 | K024224 | Liquichek Anti-Smooth Muscle Control, Positive, Catalog #129 | Bio-Rad | 2003 | — |
| +1 | K024227 | Liquichek Anti-Mitochondrial Control, Positive, Catalog #127 | Bio-Rad | 2003 | — |
| +1 | K024217 | Liquichek Ana Control, Speckled Pattern, Positive, Catalog #108 | Bio-Rad | 2003 | — |
| +1 | K024221 | Liquichek Ana Control Homogeneous Pattern Control, Posotive, Catalog #118 | Bio-Rad | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 7 | 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 DBL? 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? (7)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024230 | Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and Nucleolar… | 2003 | 0 |
| K024224 | Liquichek Anti-Smooth Muscle Control, Positive, Catalog #129 | 2003 | 0 |
| K024227 | Liquichek Anti-Mitochondrial Control, Positive, Catalog #127 | 2003 | 0 |
| K024217 | Liquichek Ana Control, Speckled Pattern, Positive, Catalog #108 | 2003 | 0 |
| K024221 | Liquichek Ana Control Homogeneous Pattern Control, Posotive, Catalog #118 | 2003 | 0 |
| K024229 | Liquichek Ana Control, Nucleolar Pattern, Positive, Catalog #111 | 2003 | 0 |
| K024231 | Liquichek Anti-Mitotic Spindle Pattern Control, Positive, Catalog #118 | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2008 | Not classified | Z-2430-2008 | 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, K024230 (Bio-Rad, 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DBL devicesDBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DBL
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · DBL
Too few DBL 510(k)s in any year since 2007 to give a median.
Recalls per year · DBL
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DBL
No MAUDE report names DBL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K792610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K792610: Kallestad Florescent Ana/Ama/Asma Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K792610
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026