# K261364: Atellica CH Acetaminophen 2 (ACTM)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jul 24, 2026 after 88 days
- Product code: LDP (Colorimetry, Acetaminophen)
- Device class: 2
- Regulation: 21 CFR 862.3030
- 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 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K261364
Methodology: https://510kreport.com/methodology