510(k) · Cleared
ClearedGSP Neonatal Total Galactose kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perkinelmer, Inc. · JIA Enzymatic Methods, Galactose
Cleared on Nov 6, 2019 as substantially equivalent to K133652 (Wallac Oy, A Subsidiary of Perkinelmer, Inc., 2014) after a 265-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Nov 6, 2019
- Review
- 265 days
- Class
- Class I
- Product code
- JIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K990654 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK990654 Quantase Total Galactose Screening Assay 500 Test KitQuantase, Ltd. · 1999 · Recalled
- 2 generations backK071649 Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models…Wallac OY · 2008 · Recalled
- 1 generation backK133652 GSP Neonatal Total Galactose KitWallac Oy, A Subsidiary of Perkinelmer, Inc. · 2014
- This deviceK190335 GSP Neonatal Total Galactose kitPerkinelmer, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990654 | Quantase Total Galactose Screening Assay 500 Test Kit | Quantase, Ltd. | 1999 | 1 |
| −2 | K071649 | Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010… | Wallac OY | 2008 | 3 |
| −1 | K133652 | GSP Neonatal Total Galactose Kit | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2014 | — |
| 0 (this device) | K190335 | GSP Neonatal Total Galactose kit | Perkinelmer, Inc. | 2019 | — |
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 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? (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 |
|---|---|---|---|
| * | K133652 | GSP Neonatal Total Galactose KitSummary page 4…I, Reserved Panel: 75 Clinical Chemistry Product Code: JIA Predicate Device: GSP Neonatal Total Galactose kit [K133652] Device Description: The GSP Neonatal Total Galactose test system measures total galactose, i.e. both galactose and galactose-1… | 2014 |
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 20 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All JIA devicesJIA Enzymatic Methods, Galactose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 GSP Neonatal Total Galactose kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia using the GSP® instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190335: GSP Neonatal Total Galactose kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190335
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026