510(k) · Cleared
Recalled · Class II · 2017Neobase Non-Derivatized MSMS Kit, Model 3040
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 Jul 9, 2009 as substantially equivalent to DEN040002 (Perkinelmer Life Sciences, Inc., 2004) after a 259-day review. Its family tree reaches back 1 generation to 2004. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 9, 2009
- Review
- 259 days
- Class
- Class II
- Product code
- NQL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN040002 (2004). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN040002 Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit…Perkinelmer Life Sciences, Inc. · 2004
- This deviceK083130 Neobase Non-Derivatized MSMS Kit, Model 3040Perkinelmer, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK093916 Neobase Non-Derivatized MSMS Kit Model 3040-001UPerkinelmer, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK173568 NeoBase 2 Non-derivatized MSMS KitWallac Oy, Subsidiary of Perkinelmer, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK193103 NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K093916Neobase Non-Derivatized MSMS Kit Model 3040-001UPerkinelmer, Inc. · 2010 · cites it directly2descendants
- K173568NeoBase 2 Non-derivatized MSMS KitWallac Oy, Subsidiary of Perkinelmer, Inc. · 2018 · 2 generations on1descendant
- K193103NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN040002 | Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model… | Perkinelmer Life Sciences, Inc. | 2004 | — |
| 0 (this device) | K083130 | Neobase Non-Derivatized MSMS Kit, Model 3040 | Perkinelmer, Inc. | 2009 | — |
| +1 | K093916 | Neobase Non-Derivatized MSMS Kit Model 3040-001U | Perkinelmer, Inc. | 2010 | — |
| +2 | K173568 | NeoBase 2 Non-derivatized MSMS Kit | Wallac Oy, Subsidiary of Perkinelmer, Inc. | 2018 | — |
| +3 | K193103 | NeoBase 2 Non-derivatized MSMS Kit | Perkinelmer, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | DEN040002 | Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970 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. | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093916 | Neobase Non-Derivatized MSMS Kit Model 3040-001U | 2010 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2017 | Class II | Z-1692-2018 | Process control | 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 succinylacetone reagent vials. |
| Nov 26, 2012 | Class II | Z-0687-2013 | Process control | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K093916 (Perkinelmer, Inc., 2010) has gone furthest, with 2 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. 2009, 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K083130 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083130: Neobase Non-Derivatized MSMS Kit, Model 3040.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083130
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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