510(k) · Cleared
ClearedNeoBase 2 Non-derivatized MSMS Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perkinelmer, Inc. · NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Cleared on Feb 7, 2020 as substantially equivalent to K173568 (Wallac Oy, Subsidiary of Perkinelmer, Inc., 2018) after a 91-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Feb 7, 2020
- Review
- 91 days
- Class
- Class II
- Product code
- NQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN040002 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backDEN040002 Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit…Perkinelmer Life Sciences, Inc. · 2004
- 3 generations backK083130 Neobase Non-Derivatized MSMS Kit, Model 3040Perkinelmer, Inc. · 2009 · Recalled
- 2 generations backK093916 Neobase Non-Derivatized MSMS Kit Model 3040-001UPerkinelmer, Inc. · 2010
- 1 generation backK173568 NeoBase 2 Non-derivatized MSMS KitWallac Oy, Subsidiary of Perkinelmer, Inc. · 2018
- This deviceK193103 NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN040002 | Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model… | Perkinelmer Life Sciences, Inc. | 2004 | — |
| −3 | K083130 | Neobase Non-Derivatized MSMS Kit, Model 3040 | Perkinelmer, Inc. | 2009 | 2 |
| −2 | K093916 | Neobase Non-Derivatized MSMS Kit Model 3040-001U | Perkinelmer, Inc. | 2010 | — |
| −1 | K173568 | NeoBase 2 Non-derivatized MSMS Kit | Wallac Oy, Subsidiary of Perkinelmer, Inc. | 2018 | — |
| 0 (this device) | K193103 | NeoBase 2 Non-derivatized MSMS Kit | Perkinelmer, Inc. | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173568 | NeoBase 2 Non-derivatized MSMS KitSummary page 6…ation: II Panel: 75 Chemistry Product Code: NQL Predicate device: NeoBase 2 Non-derivatized MSMS kit (K173568) 1… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All NQL devicesNQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NQL
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · NQL
Too few NQL 510(k)s in any year since 2007 to give a median.
Recalls per year · NQL
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQL
1in 2025
MAUDE reports naming product code NQL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (259 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193103: NeoBase 2 Non-derivatized MSMS Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193103
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026