# K180835: SEKURE Acetaminophen L3K Assay

- Pathway: 510(k) (Traditional)
- Applicant: Sekisui Diagnostics P.E.I., Inc.
- Decided: Feb 8, 2019 after 315 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 4.

## Indications for use
Intended for the in vitro quantitative measurement of acetaminophen in serum, lithium heparin plasma and sodium heparin plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

Source page: https://510kreport.com/device/K180835
Methodology: https://510kreport.com/methodology