# K080294: Astoria-Pacific Spotcheck Biotinidase Microplate Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Astoria-Pacific, Inc.
- Decided: Nov 4, 2008 after 274 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
Longest line of descent: 1 generation back to K010844 (2001). 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)
- K010844: Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13K, Astoria-Pacific, Inc. (2001) Summary page 2.

## Indications for use
This method is for the semi-quantitative determination of biotinidase, EC 3.5.1.12, activity in dried whole blood spots using a spectrophotometer. Measurement of biotinidase activity is primarily for the diagnosis and treatment of biotinidase deficiency in newborns. This method is intended for in vitro diagnostic use in screening for decreased levels of biotinidase activity and not for monitoring purposes. This device is for use by trained, qualified clinical laboratory personnel.

Source page: https://510kreport.com/device/K080294
Methodology: https://510kreport.com/methodology