510(k) · Cleared
ClearedAcetaminophen
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 18, 2022 as substantially equivalent to K081938 (Genzyme Diagnostics P.E.I., Inc., 2009) after a 525-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Feb 18, 2022
- Review
- 525 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 deviceK202644 AcetaminophenSekisui Diagnostics P.E.I., Inc. · 2022
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) | K202644 | Acetaminophen | Sekisui Diagnostics P.E.I., Inc. | 2022 | — |
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
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 5…f Legally Marketed Predicate Devices [807.92(a)(3)] Predicate Device Predicate 510(k) Number SEKURE Acetaminophen L3K Assay K081938 4. Device Description [807.92(a)(4)] Trade Name Device Description Acetaminophen List 03R7420 Tests p… | 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 17 years and passes through 3 companies; a new generation was cleared every 12.8 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. 2022, 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?
The Acetaminophen assay is used for the quantitative determination of acetaminophen in human serum or plasma on the ARCHITECT c Systems.
The Acetaminophen assay is to be used as an aid in the diagnosis and treatment of acetaminophen overdose toxicity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202644: Acetaminophen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202644
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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