510(k) · Cleared
ClearedAcetaminophen Assay for the Advia Integrated Modular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · LDP Colorimetry, Acetaminophen
Cleared on Jul 11, 2002 as substantially equivalent to K840941 (Abbott Laboratories, 1984) after a 122-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Jul 11, 2002
- Review
- 122 days
- Class
- Class II
- Product code
- LDP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K840941 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK840941 TDX AcetaminophenAbbott Laboratories · 1984
- This deviceK020792 Acetaminophen Assay for the Advia Integrated Modular SystemBayer Diagnostics Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840941 | TDX Acetaminophen | Abbott Laboratories | 1984 | — |
| 0 (this device) | K020792 | Acetaminophen Assay for the Advia Integrated Modular System | Bayer Diagnostics Corp. | 2002 | — |
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 |
|---|---|---|---|
| * | K840941 | TDX AcetaminophenSummary page 2…rformance of the ADVIA IMS Acetaminophen Assay on a Bayer ADVIA@ IMSTMis equivalent to the performance of the Acetaminophen Assay on the predicate device (Abbott TDX, K840941) and is w i h proposed manufacturing specifications. No safety and effectiveness issues have been raised.… | 1984 |
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?
- Its one ancestor has no 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?
The Buyer ADC24 M S Acetaminophen method 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020792 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020792: Acetaminophen Assay for the Advia Integrated Modular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020792
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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