510(k) · Cleared
ClearedNeobase Non-Derivatized MSMS Kit Model 3040-001U
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 Aug 23, 2010 as substantially equivalent to K083130 (Perkinelmer, Inc., 2009) after a 244-day review. Its family tree reaches back 2 generations to 2004. 2 later devices descend from it.
- Decided
- Aug 23, 2010
- Review
- 244 days
- Class
- Class II
- Product code
- NQL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN040002 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN040002 Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit…Perkinelmer Life Sciences, Inc. · 2004
- 1 generation backK083130 Neobase Non-Derivatized MSMS Kit, Model 3040Perkinelmer, Inc. · 2009 · Recalled
- This deviceK093916 Neobase Non-Derivatized MSMS Kit Model 3040-001UPerkinelmer, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK173568 NeoBase 2 Non-derivatized MSMS KitWallac Oy, Subsidiary of Perkinelmer, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK193103 NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN040002 | Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model… | Perkinelmer Life Sciences, Inc. | 2004 | — |
| −1 | K083130 | Neobase Non-Derivatized MSMS Kit, Model 3040 | Perkinelmer, Inc. | 2009 | 2 |
| 0 (this device) | 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 | — |
| +2 | K193103 | NeoBase 2 Non-derivatized MSMS Kit | Perkinelmer, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083130 | Neobase Non-Derivatized MSMS Kit, Model 3040Summary page 1…m mass spectrometry (21 CFR § 862.1055 /Product code NOQL Predicate dlevices) NeoBase Non-derivatized MVSMVS Kit, K083130 Device description: The measurement of amino acids, succinylacetone, free carnitine, and acylcarni… | 2009 |
| Kept off the family tree | K031878 | MS2 and PerkinElmer Quattro Micro platforms Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5…inElmer TOO Triple Quadrupole Mass Spectrometer System (PerkinElmer TOO platform) was compared to the predicate MS 2 and PerkinElmer Quattro Micro platforms performance, K031878. All of these are tandem mass spectrometry platforms capable of measuring the NeoBase panel of amino acids and acylcarnitines fro… |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173568 | NeoBase 2 Non-derivatized MSMS Kit | 2018 | 1 |
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 6 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K173568 (Wallac Oy, Subsidiary of Perkinelmer, Inc., 2018) has gone furthest, with 1 descendant 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. 2010, 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 Non-derivatized MSMS reagent kit (for use on the PerkinElmer TQD MSMS Screening System) 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093916 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093916: Neobase Non-Derivatized MSMS Kit Model 3040-001U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093916
Report an extraction error
Are you the manufacturer?
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