510(k) · Cleared
Recalled · 2010Quantase Total Galactose Screening Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantase, Ltd. · JIA Enzymatic Methods, Galactose
Cleared on Jun 21, 1999 after a 115-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Jun 21, 1999
- Review
- 115 days
- Class
- Class I
- Product code
- JIA
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIA? 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 26, 2010 | Not classified | Z-1562-2011 | Other | Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JIA devicesJIA Enzymatic Methods, Galactose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIA
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JIA
Too few JIA 510(k)s in any year since 2007 to give a median.
Recalls per year · JIA
No recall names JIA since 2007.
Adverse event reports per year · JIA
No MAUDE report names JIA 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 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 | — |
What is it indicated for?
The Quantase Total Galactose Screening Assay is an enzymatic colorimetric end-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newbom screening programme. The test is intended as a screening method for measuring the total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of…
Read the full statement (108 words)
The Quantase Total Galactose Screening Assay is an enzymatic colorimetric end-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newbom screening programme.
The test is intended as a screening method for measuring the total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of galactosaemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received.
The kit is NOT intended for use in monitoring the circulating concentrations of total D(+)galactose in galactosaemic patients nor to detect ante-natal galactosaemia.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990644 · printed Nov 3, 2026
Cite this page
510(k) Report. “K990644: Quantase Total Galactose Screening Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K990644
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026