# K090940: Spotcheck Blood Spot Control, Assayed

- Pathway: 510(k) (Traditional)
- Applicant: Astoria-Pacific, Inc.
- Decided: Dec 14, 2009 after 255 days
- Product code: JJT (Enzyme Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K961432 (1996). 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)
- K990827: Microplate Neonatal Galt Assay, Bio-Rad (1999) Summary page 2.

## Indications for use
SPOTCHECK Blood Spot Controls are used for monitoring assay performance during in vitro diagnostic newborn screening for deficient Galactose-1I-phosphate Uridyltransferase (GALT) and/or Biotinidase enzyme activity. Enzyme response quantitation is provided in the product insert.

Source page: https://510kreport.com/device/K090940
Methodology: https://510kreport.com/methodology