510(k) · Cleared
Recalled · Class II · 2015Uridyltransferase Kit, 50 Hour (80-4000-13K)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astoria-Pacific, Inc. · KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Cleared on Dec 11, 1997 after a 322-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Dec 11, 1997
- Review
- 322 days
- Class
- Class II
- Product code
- KQP
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (1)
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 |
|---|---|---|---|
| * | — | Sigma Galactose-1-Phosphate Uridyltransferase (Gal-PUT) Deficiency Screen Named without a submission number |
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 |
|---|---|---|---|---|
| Mar 5, 2015 | Class II | Z-1659-2015 | Nonconforming Material/Component | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the… |
No ancestor or descendant has a Class I recall.
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 Astoria-Pacific SPOTCHECK® Uridyltransferase 50-Hour Reagent Kit is for the gqualitative determination of galactose-1-phosphate uridyltransferase (EC 2.7.7.12) (GALT) activity in whole blood saturated filter paper disks, S&S 983 filter paper or equivalent, using the AP1 ™ 308 SPOTCHECK® Analyzer or the RFA-jed System. Measurements of galactose-1-phosphate uridgltransferase are used in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in screening for decreased levels of GALT enzyme activity in infants. This method is not for monitoring purposes.
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/K970277 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970277: Uridyltransferase Kit, 50 Hour (80-4000-13K).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970277
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026