510(k) · Cleared
ClearedAcetaminophen Assay (Ace), Catalogue Number 503-10
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 Mar 3, 1998 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 3, 1998
- Review
- 57 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 quantitative determination of acetaminophen in serum. For IN VITRO diagnostic use. 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…
Read the full statement (199 words)
For the quantitative determination of acetaminophen in serum. For IN VITRO diagnostic use. 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 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).
The majority of methods for measuring acetaminophen are based on spectrophotometric or chromatographic principles. Chromatographic methods are specific for the parent compound, however, they are not well suited to emergency laboratories. Spectrophotometric methods are simpler and more rapid, but do not always offer the desired specificity.
This spectrophotometric method is rapid, reliable, convenient, and specific for acetaminophen.
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/K980031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980031: Acetaminophen Assay (Ace), Catalogue Number 503-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980031
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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