# K131284: GSP Neonatal Biotinidase Kit

- Pathway: 510(k) (Traditional)
- Applicant: Wallac OY
- Decided: Nov 14, 2013 after 192 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: 2 generations back to K010844 (2001). 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)
- K090123: Neonatal Biotinidase Kit, Model 3018, Perkinelmer, Inc. (2010) Summary page 1.

## Indications for use
The GSP Neonatal Biotinidase kit is intended for the quantitative in vitro determination of human biotinidase activity in blood specimens dried on filter paper as an aid in screening newborns for biotinidase deficiency using the GSP instrument.

Source page: https://510kreport.com/device/K131284
Methodology: https://510kreport.com/methodology