# K141928: Cobas C Acetaminophen Gen.2 Assay, ACET2 Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Operations (Rdo)
- Decided: Nov 25, 2014 after 132 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002974 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002974: Emit Tox Acetaminophen Assay, Model 7A319UL; Emit Tox Ecetaminophen Calibrators, Model 7A409UL, Dade Behring, Inc. (2000) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K141928
Methodology: https://510kreport.com/methodology