# K083130: Neobase Non-Derivatized MSMS Kit, Model 3040

- Pathway: 510(k) (Traditional)
- Applicant: Perkinelmer, Inc.
- Decided: Jul 9, 2009 after 259 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN040002 (2004). 1 ancestor in all.
3 later devices descend 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)
- DEN040002: Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970, Perkinelmer Life Sciences, Inc. (2004). Our reading of the summary gave K031878, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040002, Neogram Amino Acids and Acylcarnitines Tandem Mass… (Perkinelmer Life Sciences, Inc.), granted Aug 24, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K093916: Neobase Non-Derivatized MSMS Kit Model 3040-001U (2010), 2 descendants of its own
- K173568: NeoBase 2 Non-derivatized MSMS Kit (2018), 1 descendant of its own
- K193103: NeoBase 2 Non-derivatized MSMS Kit (2020), 0 descendants of its own

## Recalls of this device
- Nov 2, 2017 · Class II · Z-1692-2018: There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacet
- Nov 26, 2012 · Class II · Z-0687-2013: Truncated V-Bottomed Microplate Wells used in assays contain defective wells.

## Indications for use
The NeoBase Non-derivatized MSMS reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free-carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes (Table 1) 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/K083130
Methodology: https://510kreport.com/methodology