510(k) · Cleared
Recalled · Class II · 2026GSP Neonatalgalt Kit, Model 3303-001U
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perkinelmer, Inc. · KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Cleared on Jun 11, 2010 as substantially equivalent to K950803 (Isolab, Inc., 1995) after a 149-day review. Its family tree reaches back 1 generation to 1995. It has been recalled once.
- Decided
- Jun 11, 2010
- Review
- 149 days
- Class
- Class II
- Product code
- KQP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950803 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950803 Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000…Isolab, Inc. · 1995 · Recalled
- This deviceK100101 GSP Neonatalgalt Kit, Model 3303-001UPerkinelmer, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950803 | Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 Sample | Isolab, Inc. | 1995 | 2 |
| 0 (this device) | K100101 | GSP Neonatalgalt Kit, Model 3303-001U | Perkinelmer, Inc. | 2010 | — |
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 |
|---|---|---|---|
| * | K950803 | Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 SampleSummary page 1…duct Code: (KQP) Predicate device: Neonatal GALT (formerly Isolab Galactose-1I-Phosphate Uridyl Tranferase test) (K950803) Device Description: The GSPT11I Neonatal GALT assay is an adaptation of the quantitative… | 1995 |
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 |
|---|---|---|---|---|
| May 18, 2026 | Class II | Z-2713-2026 | Nonconforming Material/Component | Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a 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. 2010, this device’s year, is highlighted.
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?
The GSP Neonatal GALT kit is intended for the quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity in blood specimens dried on filter paper as an aid in screening newborns for classical galactosemia caused by GALT deficiency using the GSPTM instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100101: GSP Neonatalgalt Kit, Model 3303-001U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100101
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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