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
Wallac Oy, Subsidiary of Perkinelmer, Inc. · NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Cleared on Sep 4, 2018 as substantially equivalent to K093916 (Perkinelmer, Inc., 2010) after a 288-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it.
- Decided
- Sep 4, 2018
- Review
- 288 days
- Class
- Class II
- Product code
- NQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN040002 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN040002 Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit…Perkinelmer Life Sciences, Inc. · 2004
- 2 generations backK083130 Neobase Non-Derivatized MSMS Kit, Model 3040Perkinelmer, Inc. · 2009 · Recalled
- 1 generation backK093916 Neobase Non-Derivatized MSMS Kit Model 3040-001UPerkinelmer, Inc. · 2010
- This deviceK173568 NeoBase 2 Non-derivatized MSMS KitWallac Oy, Subsidiary of Perkinelmer, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK193103 NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K193103NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN040002 | Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model… | Perkinelmer Life Sciences, Inc. | 2004 | — |
| −2 | K083130 | Neobase Non-Derivatized MSMS Kit, Model 3040 | Perkinelmer, Inc. | 2009 | 2 |
| −1 | K093916 | Neobase Non-Derivatized MSMS Kit Model 3040-001U | Perkinelmer, Inc. | 2010 | — |
| 0 (this device) | K173568 | NeoBase 2 Non-derivatized MSMS Kit | Wallac Oy, Subsidiary of Perkinelmer, Inc. | 2018 | — |
| +1 | K193103 | NeoBase 2 Non-derivatized MSMS Kit | Perkinelmer, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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.
Top candidate predicates for a new NQL device
- #1 K193103 NeoBase 2 Non-derivatized MSMS Kitscore -0.3 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K093916 | Neobase Non-Derivatized MSMS Kit Model 3040-001USummary page 6…linical Chemistry (75) Product Code: NQL Predicate device: PerkinElmer NeoBase Non-derivatized MSMS reagent kit (K093916) Page | 1 Wallac Oy,… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | 2020 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K193103 (Perkinelmer, Inc., 2020) has gone furthest, with 0 descendants of its own.
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. 2018, 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 screening
newborns for metabolic disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173568: 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/K173568
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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