510(k) · Cleared
ClearedAtellica CH Acetaminophen 2 (ACTM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · LDP Colorimetry, Acetaminophen
Cleared on Jul 24, 2026 as substantially equivalent to K002974 (Dade Behring, Inc., 2000) after an 88-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jul 24, 2026
- Review
- 88 days
- Class
- Class II
- Product code
- LDP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002974 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002974 Emit Tox Acetaminophen Assay, Model 7A319UL; Emit Tox Ecetaminophen…Dade Behring, Inc. · 2000
- This deviceK261364 Atellica CH Acetaminophen 2 (ACTM)Siemens Healthcare Diagnostics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002974 | Emit Tox Acetaminophen Assay, Model 7A319UL; Emit Tox Ecetaminophen… | Dade Behring, Inc. | 2000 | — |
| 0 (this device) | K261364 | Atellica CH Acetaminophen 2 (ACTM) | Siemens Healthcare Diagnostics, Inc. | 2026 | — |
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 K202644 Acetaminophenscore 3.2 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K002974 | Emit Tox Acetaminophen Assay, Model 7A319UL; Emit Tox Ecetaminophen Calibrators, Model…Summary page 7…Comparison The predicate device for the Atellica CH Acetaminophen 2 (ACTM) assay is the Emit tox Acetaminophen assay, which was submitted and cleared by FDA under 510(k) K002974 on October 11, 2000. Details for the predicate device are outlined below: Predicate Device Product Name… | 2000 |
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.
- 1 other device also cites its predicate K002974.
How does its category compare?
All LDP devicesLDP Colorimetry, Acetaminophen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Atellica CH Acetaminophen 2 (ACTM) assay is for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (K2 EDTA, lithium heparin, sodium heparin) using the Atellica CH Analyzer. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261364: Atellica CH Acetaminophen 2 (ACTM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261364
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026