# K013757: Roche Acetaminophen

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 8, 2002 after 56 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COBAS INTEGRA Acetaminophen Assay: named in the summary without a submission number

## Most influential descendants
- K110726: Roche Acetaminophen Assay (2011), 0 descendants of its own

## Recalls of this device
- Dec 7, 2010 · Not classified · Z-1679-2011: The current product labeling for Acetaminophen does not provide specific interference information for bilirubin, hemoglobin or lipemia. Additional testing has been performed to quantify the impact of 

## Indications for use
For the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of afg\ammophcn ov‘e/%/)

Source page: https://510kreport.com/device/K013757
Methodology: https://510kreport.com/methodology