510(k) · Cleared
Recalled · Class II · 2017Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Diagnostics P.E.I., Inc. · LDP Colorimetry, Acetaminophen
Cleared on May 1, 2009 as substantially equivalent to K042330 (Diagnostic Chemicals, Ltd., 2005) after a 297-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- May 1, 2009
- Review
- 297 days
- Class
- Class II
- Product code
- LDP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042330 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK042330 Acetaminophen-SL AssayDiagnostic Chemicals, Ltd. · 2005 · Recalled
- This deviceK081938 Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10…Genzyme Diagnostics P.E.I., Inc. · 2009
- Descendant · cites it directly · 0 of its ownK202644 AcetaminophenSekisui Diagnostics P.E.I., Inc. · 2022
- Descendant · cites it directly · 0 of its ownK180835 SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc. · 2019
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 |
|---|---|---|---|---|---|
| −1 | K042330 | Acetaminophen-SL Assay | Diagnostic Chemicals, Ltd. | 2005 | 2 |
| 0 (this device) | K081938 | Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30 | Genzyme Diagnostics P.E.I., Inc. | 2009 | — |
| +1 | K202644 | Acetaminophen | Sekisui Diagnostics P.E.I., Inc. | 2022 | — |
| +1 | K180835 | SEKURE Acetaminophen L3K Assay | Sekisui Diagnostics P.E.I., Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K042330 | Acetaminophen-SL AssaySummary page 1…FDA Regulation Name: 862.3030 Colorimetry, Acetaminophen FDA Product Code: LDP Predicate Device: Genzyme Diagnostics P.E.I. Inc. (K042330) Device Description: For the quantitative measurement of acetaminophen in serum and plasma. Measurement of… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2017 | Class II | Z-3118-2017 | Nonconforming Material/Component | Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification. |
| Jan 22, 2016 | Class II | Z-1171-2016 | Device Design | Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K202644 (Sekisui Diagnostics P.E.I., Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LDP devicesLDP Colorimetry, Acetaminophen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
For the quantitative measurement of acetaminophen in serum and 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/K081938 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081938: Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081938
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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