# K161364: BinaxNOW G6PD Test

- Pathway: 510(k) (Special)
- Applicant: Alere Scarborough, Inc.
- Decided: Jun 17, 2016 after 31 days
- Product code: JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening)
- Device class: 2
- Regulation: 21 CFR 864.7360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933934 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080003: Binaxnow G6PD Test, Binax, Inc. (2008) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K161364
Methodology: https://510kreport.com/methodology