# K090123: Neonatal Biotinidase Kit, Model 3018

- Pathway: 510(k) (Traditional)
- Applicant: Perkinelmer, Inc.
- Decided: Mar 5, 2010 after 408 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K131284: GSP Neonatal Biotinidase Kit (2013), 0 descendants of its own

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

Source page: https://510kreport.com/device/K090123
Methodology: https://510kreport.com/methodology