# K990957: Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13K

- Pathway: 510(k) (Traditional)
- Applicant: Astoria-Pacific, Inc.
- Decided: May 11, 1999 after 50 days
- Product code: JBL (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative)
- 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 K790211 (1979). 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)
- K790211: Dehydrogenose, Glucose Phosphate, Sigma Chemical Co. (1979) Summary page 2.

## Indications for use
The Astoria-Pacific SPOTCHECK G6PD 50 Hour Reagent Kit is intended for the semi-quantitative determination of glucose-6-phosphate dehydrogenase activity in erythrocytes using the Astoria-Pacific SPOTCHECK Analyzer. Measurements of glucose-6-phosphate dehydrogenase activity are used primarily in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a G6PD deficiency. It is for in vitro diagnostic use primarily as an aid in screening for decreased levels of G6PD enzyme activity. This device is for use by trained, qualified laboratory personnel.

Source page: https://510kreport.com/device/K990957
Methodology: https://510kreport.com/methodology