510(k) · Cleared
Recalled · Class II · 2012Acetaminophen-SL Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Chemicals, Ltd. · LDP Colorimetry, Acetaminophen
Cleared on Jan 7, 2005 after a 133-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 7, 2005
- Review
- 133 days
- Class
- Class II
- Product code
- LDP
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK042330 Acetaminophen-SL AssayDiagnostic Chemicals, Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK081938 Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10…Genzyme Diagnostics P.E.I., Inc. · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK202644 AcetaminophenSekisui Diagnostics P.E.I., Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK180835 SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc. · 2019
Most influential descendants
Showing 3 of 3 · See all- K081938Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30Genzyme Diagnostics P.E.I., Inc. · 2009 · cites it directly2descendants
- K202644AcetaminophenSekisui Diagnostics P.E.I., Inc. · 2022 · 2 generations on0descendants
- K180835SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042330 | Acetaminophen-SL Assay | Diagnostic Chemicals, Ltd. | 2005 | — |
| +1 | K081938 | Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30 | Genzyme Diagnostics P.E.I., Inc. | 2009 | 2 |
| +2 | K202644 | Acetaminophen | Sekisui Diagnostics P.E.I., Inc. | 2022 | — |
| +2 | K180835 | SEKURE Acetaminophen L3K Assay | Sekisui Diagnostics P.E.I., Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K081938 | Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30 | 2009 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 29, 2012 | Class II | Z-1902-2012 | Storage | Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery. |
| Jun 1, 2007 | Not classified | Z-1233-2007 | Other | Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081938 (Genzyme Diagnostics P.E.I., Inc., 2009) has gone furthest, with 2 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.
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 Diagnostic Chemicals Limited's Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose. This assay consists of two reagents and a calibrator.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042330 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042330: Acetaminophen-SL Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042330
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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