510(k) · Cleared
ClearedBinaxNOW G6PD Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere Scarborough, Inc. · JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Cleared on Jun 17, 2016 as substantially equivalent to K080003 (Binax, Inc., 2008) after a 31-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jun 17, 2016
- Review
- 31 days
- Class
- Class II
- Product code
- JBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933934 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 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? (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 |
|---|---|---|---|
| * | K080003 | Binaxnow G6PD TestSummary page 4…cytic glucose-6-phosphate dehydrogenase assay. (per 21 CFR 864.7360) CLASSIFICATION Class II PRODUCT CODE JBF PANEL Hematology PREDICATE DEVICES BinaxNOW® G6PD Test, K080003 BinaxNOW® G6PD Test Page 1 Special 510(k) Notification -… | 2008 |
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 21 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- None of the 2 ancestors has a recall.
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. 2016, this device’s year, is highlighted.
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?
The BinaxNOW® G6PD (Glucose-6-Phosphate Dehydrogenase) Test is an in vitro enzyme chromatographic test for the qualitative detection of G6PD enzyme activity in human venous whole blood, collected in heparin or ethylenediaminetetraacetic acid (EDTA). The BinaxNOW® G6PD Test is a visual screening test used for differentiating normal from deficient G6PD activity levels in whole blood and is intended to aid in the identification of people with G6PD deficiency. Samples which generate deficient results should be assayed using a quantitative G6PD test method to verify the deficiency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161364: BinaxNOW G6PD Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161364
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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