# K010844: Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13K

- Pathway: 510(k) (Traditional)
- Applicant: Astoria-Pacific, Inc.
- Decided: Sep 21, 2001 after 184 days
- Product code: NAK (System, Test, Biotinidase)
- Device class: 2
- Regulation: 21 CFR 862.1118
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K090123: Neonatal Biotinidase Kit, Model 3018 (2010), 1 descendant of its own
- K131284: GSP Neonatal Biotinidase Kit (2013), 0 descendants of its own
- K080294: Astoria-Pacific Spotcheck Biotinidase Microplate Reagent Kit (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K010844
Methodology: https://510kreport.com/methodology