510(k) · Cleared
ClearedCobas C Acetaminophen Gen.2 Assay, ACET2 Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Operations (Rdo) · DKB Calibrators, Drug Mixture
Cleared on Nov 25, 2014 as substantially equivalent to K002974 (Dade Behring, Inc., 2000) after a 132-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Nov 25, 2014
- Review
- 132 days
- Class
- Class II
- Product code
- DKB
- 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 deviceK141928 Cobas C Acetaminophen Gen.2 Assay, ACET2 CalibratorRoche Diagnostics Operations (Rdo) · 2014
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) | K141928 | Cobas C Acetaminophen Gen.2 Assay, ACET2 Calibrator | Roche Diagnostics Operations (Rdo) | 2014 | — |
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 DKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K002974 | Emit Tox Acetaminophen Assay, Model 7A319UL; Emit Tox Ecetaminophen Calibrators, Model…Summary page 6…equivalence to the Siemens Emit ® device tox™ Acetaminophen Assay and the Siemens Emit ® tox™ Acetaminophen Calibrators which were both cleared in k002974. Continued on next page… | 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 DKB devicesDKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DKB
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DKB
Too few DKB 510(k)s in any year since 2007 to give a median.
Recalls per year · DKB
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKB
1in 2017
MAUDE reports naming product code DKB, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 2 | 1 |
| 2012 | 1 | — | 1 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
cobas c Acetaminophen Gen.2 assay:
The cobas c Acetaminophen Gen.2 assay is an in vitro diagnostic test for the quantitative determination of acetaminophen in serum and plasma for use in the diagnosis of acetaminophen overdose in serum and plasma on Roche/Hitachi cobas c systems.
ACET2 calibrator:
The ACET2 calibrator is for use in the calibration of the Acetaminophen Gen.2 Roche assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141928: Cobas C Acetaminophen Gen.2 Assay, ACET2 Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141928
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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