# K202644: Acetaminophen

- Pathway: 510(k) (Traditional)
- Applicant: Sekisui Diagnostics P.E.I., Inc.
- Decided: Feb 18, 2022 after 525 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: 2 generations back to K042330 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081938: Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30, Genzyme Diagnostics P.E.I., Inc. (2009) Summary page 5.

## Indications for use
The Acetaminophen assay is used for the quantitative determination of acetaminophen in human serum or plasma on the ARCHITECT c Systems. The Acetaminophen assay is to be used as an aid in the diagnosis and treatment of acetaminophen overdose toxicity.

Source page: https://510kreport.com/device/K202644
Methodology: https://510kreport.com/methodology