510(k) · Cleared
Recalled · Class II · 2015G6PDH, Glucose-6-Phoshate Dehydrogenase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pointe Scientific, Inc., · JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Cleared on Mar 31, 2003 after a 117-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 31, 2003
- Review
- 117 days
- Class
- Class II
- Product code
- JBF
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK024006 G6PDH, Glucose-6-Phoshate DehydrogenasePointe Scientific, Inc., · 2003
- Descendant · cites it directly · 0 of its ownK201049 Finder G6PDBaebies, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K201049Finder G6PDBaebies, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024006 | G6PDH, Glucose-6-Phoshate Dehydrogenase | Pointe Scientific, Inc., | 2003 | — |
| +1 | K201049 | Finder G6PD | Baebies, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JBF device
- #1 K201049 Finder G6PDscore 4.0 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201049 | Finder G6PD | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2015 | Class II | Z-2487-2015 | Nonconforming Material/Component | A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specification result prior to the current reconstitution claim… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K201049 (Baebies, Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JBF devicesJBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JBF
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JBF
Too few JBF 510(k)s in any year since 2007 to give a median.
Recalls per year · JBF
No recall names JBF since 2007.
Adverse event reports per year · JBF
4in 2023
MAUDE reports naming product code JBF, not matched to any one device; reports are not rates.
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 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the quantitative determination of glucose-6-phosphate dehydrogenase
(GGPD) in blood at 340 nm. For in vitro diagnostic use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K024006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024006: G6PDH, Glucose-6-Phoshate Dehydrogenase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024006
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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