# K193103: NeoBase 2 Non-derivatized MSMS Kit

- Pathway: 510(k) (Traditional)
- Applicant: Perkinelmer, Inc.
- Decided: Feb 7, 2020 after 91 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: 4 generations back to DEN040002 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173568: NeoBase 2 Non-derivatized MSMS Kit, Wallac Oy, Subsidiary of Perkinelmer, Inc. (2018) Summary page 6.

## 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. Table 1. Analytes measured by the NeoBase 2 Non-derivatized MSMS kit. ANALYTE NAME ABBREVIATION Amino acids Alanine Ala Arginine Arg Argininosuccinic acid Asa Citrulline Cit Glutamine\Lysine 1 Gln\Lys Glutamic acid Glu Glycine Gly Leucine\Isoleucine\Hydroxyproline 1 Leu\Ile\Pro-OH Methionine Met Ornithine Orn Phenylalanine Phe Proline Pro Tyrosine Tyr Valine Val Carnitines Free carnitine C0 Acetylcarnitine C2 Propionylcarnitine C3 Malonylcarnitine\3-Hydroxy-butyrylcarnitine 1 C3DC\C4OH Butyrylcarnitine C4 Methylmalonyl\3-Hydroxy-isovalerylcarnitine 1 C4DC\C5OH Isovalerylcarnitine C5 Tiglylcarnitine C5:1 Glutarylcarnitine\3-Hydroxy-hexanoylcarnitine 1 C5DC\C6OH Hexanoylcarnitine C6 Adipylcarnitine C6DC 1 Analytes in these rows are either isomers or isobars and cannot be distinguished in the tandem mass spectrometry experiment. Table 1 (continued): Analytes measured by the NeoBase 2 Non-derivatized MSMS kit. Octanoylcarnitine C8 Octenoylcarnitine C8:1 Decanoylcarnitine C10 Decenoylcarnitine C10:1 Decadienoylcarnitine C10:2 Dodecanoylcarnitine C12 Dodecenoylcarnitine C12:1 Tetradecanoylcarnitine (Myristoylcarnitine) C14 Tetradecenoylcarnitine C14:1 Tetradecadienoylcarnitine C14:2 3-Hydroxy-tetradecanoylcarnitine C14OH Hexadecanoylcarnitine (Palmitoylcarnitine) C16 Hexadecenoylcarnitine C16:1 3-Hydroxy-hexadecanoylcarnitine C16OH 3-Hydroxy-hexadecenoylcarnitine\ C16:1OH\C17 Heptadecanoylcarnitine 1 Octadecanoylcarnitine (Stearoylcarnitine) C18 Octadecenoylcarnitine (Oleylcarnitine) C18:1 Octadecadienoylcarnitine (Linoleylcarnitine) C18:2 3-Hydroxy-octadecanoylcarnitine C18OH 3-Hydroxy-octadecenoylcarnitine C18:1OH 3-Hydroxy-octadecadienoylcarnitine C18:2OH Ketones Succinylacetone SA Nucleosides Adenosine ADO 2’-deoxyadenosine D-ADO Lysophospholipids C24:0 lysophosphatidylcholine C24:0-LPC C26:0 lysophosphatidylcholine C26:0-LPC 1 Analytes in these rows are either isomers or isobars and cannot be distinguished in the tandem mass spectrometry experiment.

Source page: https://510kreport.com/device/K193103
Methodology: https://510kreport.com/methodology