510(k) · Cleared
ClearedBio-Rad Coda Neonatal Galt Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Cleared on Nov 4, 1999 as substantially equivalent to K990827 (Bio-Rad, 1999) and 1 other predicate after a 16-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Nov 4, 1999
- Review
- 16 days
- Class
- Class II
- Product code
- KQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961432 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 KQP? 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? (2)
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 |
|---|---|---|---|
| * | K990827 | Microplate Neonatal Galt Assay Our OCR of the scanned summary read K998027, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Microplate Neonatal GALT Assay”. | 1999 |
| * | K961432 | Radias Galt TestSummary page 1…o-Rad CODA Neonatal GALT Assay Galactose-1-phosphate uridyl transferase test system Microplate Neonatal GALT Assay K998027 Bio-Rad Laboratories, Inc. RADIAS GALT Assay K961432 Bio-Rad Laboratories, Inc. This assay is for the qualitative determination of galactose- 1-phosphate uridyl transferase activity… | 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 3 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K990827.
How does its category compare?
All KQP devicesKQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KQP
2in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KQP
Too few KQP 510(k)s in any year since 2007 to give a median.
Recalls per year · KQP
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KQP
No MAUDE report names KQP 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 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 | 0 | — | 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 | — | 1 | — |
What is it indicated for?
This assay is for the qualitative determination of galactose-1-phosphate uridyl transferase activity in dried blood spot samples using the Bio-Rad CODA Analyzer. Measurements of GALT are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.
For in vitro diagnostic use only.
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/K993536 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993536: Bio-Rad Coda Neonatal Galt Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993536
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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