510(k) · Cleared
ClearedAcetaminophen-SL Assay, Catalogue # 505-10, 505-30.
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 May 12, 1998 after a 50-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 12, 1998
- Review
- 50 days
- Class
- Class II
- Product code
- LDP
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
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.
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?
For the determination of acetaminophen in human serum. Acetaminophen (paracetamol) is used as an analgesic in many different formulations (1). While therapeutic doses rarely cause adverse side effects, the effect of long term treatment with acetaminophen is unclear. Cases have been reported where chronic excessive use of acetaminophen has led to hepatotoxicity and nephrotoxicity (2,3). In cases of acute overdosage, acetaminophen can cause severe hepatic…
Read the full statement (146 words)
For the determination of acetaminophen in human serum. Acetaminophen (paracetamol) is used as
an analgesic in many different formulations (1). While therapeutic doses rarely cause adverse side
effects, the effect of long term treatment with acetaminophen is unclear. Cases have been reported
where chronic excessive use of acetaminophen has led to hepatotoxicity and nephrotoxicity (2,3).
In cases of acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic
failure if untreated (4,5,6).
The management of acetaminophen overdose requires early recognition of the drug in the
bloodstream. Toxicity is generally reported at concentrations over 1324 pmol/L (20 mg/dL). N-
acetylcysteine has been used as an antidote in conjunction with intensive support care. Early
diagnosis of acetaminophen-induced hepatotoxicity is important since initiation of therapy within
8 hours of ingestion lessens the potential for hepatic injury, and decreases the mortality rate (7).
For quantitative, in vitro, diagnostic use.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981059: Acetaminophen-SL Assay, Catalogue # 505-10, 505-30..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981059
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026