510(k) · Cleared
ClearedSEKURE Acetaminophen L3K Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sekisui Diagnostics P.E.I., Inc. · LDP Colorimetry, Acetaminophen
Cleared on Feb 8, 2019 as substantially equivalent to K081938 (Genzyme Diagnostics P.E.I., Inc., 2009) after a 315-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Feb 8, 2019
- Review
- 315 days
- Class
- Class II
- Product code
- LDP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042330 (2005). No later device cites it as a predicate yet.
- Root · 2 generations backK042330 Acetaminophen-SL AssayDiagnostic Chemicals, Ltd. · 2005 · Recalled
- 1 generation backK081938 Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10…Genzyme Diagnostics P.E.I., Inc. · 2009 · Recalled
- This deviceK180835 SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042330 | Acetaminophen-SL Assay | Diagnostic Chemicals, Ltd. | 2005 | 2 |
| −1 | K081938 | Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30 | Genzyme Diagnostics P.E.I., Inc. | 2009 | 2 |
| 0 (this device) | K180835 | SEKURE Acetaminophen L3K Assay | Sekisui Diagnostics P.E.I., Inc. | 2019 | — |
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 LDP? 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 LDP device
- #1 K261364 Atellica CH Acetaminophen 2 (ACTM)score 11.7 · 1 generation · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K081938 | Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30Summary page 4…f Legally Marketed Predicate Devices [807.92(a)(3)] Predicate Device Predicate 510(k) Number SEKURE Acetaminophen L3K Assay K081938 SEKISUI DIAGNOSTICS P.E.I. INC. Acetaminophen L3K Assay _________________________________________________________… | 2009 |
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 14 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K081938.
How does its category compare?
All LDP devicesLDP Colorimetry, Acetaminophen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LDP
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LDP
Too few LDP 510(k)s in any year since 2007 to give a median.
Recalls per year · LDP
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDP
3in 2025
MAUDE reports naming product code LDP, 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 | — | 1 | 6 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 2 | 5 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 1 | 4 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Intended for the in vitro quantitative measurement of acetaminophen in serum, lithium heparin plasma and sodium heparin plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180835: SEKURE Acetaminophen L3K Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180835
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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