510(k) · Cleared
ClearedRadias Galt Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Oct 28, 1996 after a 196-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 28, 1996
- Review
- 196 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK961432 Radias Galt TestBio-Rad · 1996
- Descendant · cites it directly · 3 of its ownK990827 Microplate Neonatal Galt AssayBio-Rad · 1999
- Descendant · 2 generations on · 0 of its ownK102643 Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK090940 Spotcheck Blood Spot Control, AssayedAstoria-Pacific, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK993536 Bio-Rad Coda Neonatal Galt AssayBio-Rad · 1999
Most influential descendants
Showing 4 of 4 · See all- K990827Microplate Neonatal Galt AssayBio-Rad · 1999 · cites it directly3descendants
- K102643Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc. · 2011 · 2 generations on0descendants
- K090940Spotcheck Blood Spot Control, AssayedAstoria-Pacific, Inc. · 2009 · 2 generations on0descendants
- K993536Bio-Rad Coda Neonatal Galt AssayBio-Rad · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961432 | Radias Galt Test | Bio-Rad | 1996 | — |
| +1 | K990827 | Microplate Neonatal Galt Assay | Bio-Rad | 1999 | — |
| +2 | K102643 | Spotcheck Neonatal Galt Microplate Reagent Kit | Astoria-Pacific, Inc. | 2011 | — |
| +2 | K090940 | Spotcheck Blood Spot Control, Assayed | Astoria-Pacific, Inc. | 2009 | — |
| +1 | K993536 | Bio-Rad Coda Neonatal Galt Assay | Bio-Rad | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 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 JJX? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K990827 (Bio-Rad, 1999) has gone furthest, with 3 descendants of its own.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K961432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961432: Radias Galt Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961432
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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