# K201049: Finder G6PD

- Pathway: 510(k) (Traditional)
- Applicant: Baebies, Inc.
- Decided: Sep 14, 2022 after 876 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: 1 generation back to K024006 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024006: G6PDH, Glucose-6-Phoshate Dehydrogenase, Pointe Scientific, Inc., (2003) Summary page 4.

## Indications for use
The FINDER G6PD test is intended for semi-quantitative measurement of glucose-6-phosphate dehydrogenase in venous whole blood specimens collected in lithium heparin tubes, for the identification of G6PD deficient samples. The FINDER G6PD test is intended to be used with the FINDER Instrument in point of care or clinical laboratory settings.

Source page: https://510kreport.com/device/K201049
Methodology: https://510kreport.com/methodology