# K173568: NeoBase 2 Non-derivatized MSMS Kit

- Pathway: 510(k) (Traditional)
- Applicant: Wallac Oy, Subsidiary of Perkinelmer, Inc.
- Decided: Sep 4, 2018 after 288 days
- Product code: NQL (System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry)
- Device class: 2
- Regulation: 21 CFR 862.1055
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN040002 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093916: Neobase Non-Derivatized MSMS Kit Model 3040-001U, Perkinelmer, Inc. (2010) Summary page 6.

## Most influential descendants
- K193103: NeoBase 2 Non-derivatized MSMS Kit (2020), 0 descendants of its own

## Indications for use
The NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations (Table 1) with a tandem mass spectrometer from newborn heel prick blood specimens dried on filter paper. Quantitative analysis of these analytes and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

Source page: https://510kreport.com/device/K173568
Methodology: https://510kreport.com/methodology