510(k) · Cleared
ClearedSpotcheck Neonatal Total Galactose Microplate Reagent Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astoria-Pacific, Inc. · JIA Enzymatic Methods, Galactose
Cleared on Jun 20, 2013 as substantially equivalent to K991498 (Neometrics, Inc., 1999) after a 435-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 20, 2013
- Review
- 435 days
- Class
- Class I
- Product code
- JIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991498 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991498 Accuwell Total Galactose, Model 6010-EgalNeometrics, Inc. · 1999
- This deviceK121101 Spotcheck Neonatal Total Galactose Microplate Reagent KitAstoria-Pacific, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991498 | Accuwell Total Galactose, Model 6010-Egal | Neometrics, Inc. | 1999 | — |
| 0 (this device) | K121101 | Spotcheck Neonatal Total Galactose Microplate Reagent Kit | Astoria-Pacific, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K991498 | Accuwell Total Galactose, Model 6010-EgalSummary page 2…3. Identification of the legally-mérketed device for which substantial equivalence is claimed. Product Classification Regulation Number 21 CFR 862.1310 510(k) Number K991498 Classification Panel Clinical Chemistry Product Code JIA Device Classification Class | Product Nomenclature Common Name Enzyma… | 1999 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JIA devicesJIA Enzymatic Methods, Galactose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 SPOTCHECK® Neonatal Total Galactose Microplate Reagent Kit is for the quantitative determination of the concentration of Total Galactose (galactose (Gal) + galactose-1-phosphate (Gal-1-P)) in whole blood saturated filter paper disks, using a microplate absorbance reader or SPOTCHECK Pro. Measurements of Total Galactose are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening for increased concentrations of Total Galactose, and 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/K121101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121101: Spotcheck Neonatal Total Galactose Microplate Reagent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121101
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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