510(k) · Cleared
Recalled · Class II · 2012Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallac OY · JIA Enzymatic Methods, Galactose
Cleared on Aug 7, 2008 as substantially equivalent to K990654 (Quantase, Ltd., 1999) after a 416-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 7, 2008
- Review
- 416 days
- Class
- Class I
- Product code
- JIA
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990654 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK990654 Quantase Total Galactose Screening Assay 500 Test KitQuantase, Ltd. · 1999 · Recalled
- This deviceK071649 Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models…Wallac OY · 2008
- Descendant · cites it directly · 1 of its ownK133652 GSP Neonatal Total Galactose KitWallac Oy, A Subsidiary of Perkinelmer, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK190335 GSP Neonatal Total Galactose kitPerkinelmer, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990654 | Quantase Total Galactose Screening Assay 500 Test Kit | Quantase, Ltd. | 1999 | 1 |
| 0 (this device) | K071649 | Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010… | Wallac OY | 2008 | — |
| +1 | K133652 | GSP Neonatal Total Galactose Kit | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2014 | — |
| +2 | K190335 | GSP Neonatal Total Galactose kit | Perkinelmer, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
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 |
|---|---|---|---|
| * | K990654 | Quantase Total Galactose Screening Assay 500 Test KitSummary page 1…JIA Tm Predicate device BioRad Quantase Neonatal Total Galactose Screening Assay (k990654) Description of The Neonatal Total Galactose kit makes use of a fluorescent galactose oxidase method. the device… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133652 | GSP Neonatal Total Galactose Kit | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 26, 2012 | Class II | Z-0688-2013 | Process control | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. |
| Nov 26, 2012 | Class II | Z-0689-2013 | Process control | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. |
| Nov 26, 2012 | Class II | Z-0690-2013 | Process control | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K133652 (Wallac Oy, A Subsidiary of Perkinelmer, Inc., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JIA devicesJIA Enzymatic Methods, Galactose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
This 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071649 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071649: Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071649
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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