# K110726: Roche Acetaminophen Assay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Dec 23, 2011 after 282 days
- Product code: LDP (Colorimetry, Acetaminophen)
- Device class: 2
- Regulation: 21 CFR 862.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954992 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991598: Cobas Integra Acetaminophen, Roche Diagnostics Corp. (1999) Summary page 1.
- K013757: Roche Acetaminophen, Roche Diagnostics Corp. (2002) Summary page 1.
- K060373: Cobas 6000 Series System, Roche Diagnostics (2006) Summary page 1.

## Recalls of this device
- Jan 2, 2018 · Class II · Z-1519-2018: 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 Limi

## Indications for use
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.

Source page: https://510kreport.com/device/K110726
Methodology: https://510kreport.com/methodology