# K024006: G6PDH, Glucose-6-Phoshate Dehydrogenase

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Mar 31, 2003 after 117 days
- Product code: JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening)
- Device class: 2
- Regulation: 21 CFR 864.7360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K201049: Finder G6PD (2022), 0 descendants of its own

## Recalls of this device
- May 19, 2015 · Class II · Z-2487-2015: 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

## Indications for use
For the quantitative determination of glucose-6-phosphate dehydrogenase (GGPD) in blood at 340 nm. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K024006
Methodology: https://510kreport.com/methodology