510(k) · Cleared
Recalled · Class II · 2018Roche Acetaminophen Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · LDP Colorimetry, Acetaminophen
Cleared on Dec 23, 2011 as substantially equivalent to K991598 (Roche Diagnostics Corp., 1999) and 2 other predicates after a 282-day review. Its family tree reaches back 2 generations to 1996. It has been recalled once.
- Decided
- Dec 23, 2011
- Review
- 282 days
- Class
- Class II
- Product code
- LDP
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K954992 (1996). 6 ancestors in all, the oldest K953239 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954992 | Roche Cobas Integra Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1996 | — |
| −1 | K991598 | Cobas Integra Acetaminophen | Roche Diagnostics Corp. | 1999 | 1 |
| 0 (this device) | K110726 | Roche Acetaminophen Assay | Roche Diagnostics | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K991598 | Cobas Integra AcetaminophenSummary page 1…Product code LDP Predicate We claim substantial equivalence to the following predicate devices: Roche Device COBAS Integra Acetaminophen assay (K99 1598), the Roche/H-itachi Acetaminophen assay (K013757) and the cobas c501 Acetaminophen assay (K0… | 1999 |
| * | K013757 | Roche AcetaminophenSummary page 1…lence to the following predicate devices: Roche Device COBAS Integra Acetaminophen assay (K99 1598), the Roche/H-itachi Acetaminophen assay (K013757) and the cobas c501 Acetaminophen assay (K060373). Intended use / The Roche Acetaminophen assay is an in… | 2002 |
| * | K060373 | Cobas 6000 Series SystemSummary page 1…OBAS Integra Acetaminophen assay (K99 1598), the Roche/H-itachi Acetaminophen assay (K013757) and the cobas c501 Acetaminophen assay (K060373). Intended use / The Roche Acetaminophen assay is an in vitro test for the quantitative Indications for determination of… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2018 | Class II | Z-1519-2018 | Error in labeling | The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interference section: "In very… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- 5 of the 6 ancestors have a recall of any class.
How does its category compare?
All LDP devicesLDP Colorimetry, Acetaminophen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Roche Acetaminophen assay is an in vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma on Roche COBAS Integra, Roche/Hitachi and cobas c system analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110726 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110726: Roche Acetaminophen Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110726
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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