# K081938: Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Diagnostics P.E.I., Inc.
- Decided: May 1, 2009 after 297 days
- Product code: LDP (Colorimetry, Acetaminophen)
- Device class: 2
- Regulation: 21 CFR 862.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042330 (2005). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042330: Acetaminophen-SL Assay, Diagnostic Chemicals, Ltd. (2005) Summary page 1.

## Most influential descendants
- K202644: Acetaminophen (2022), 0 descendants of its own
- K180835: SEKURE Acetaminophen L3K Assay (2019), 0 descendants of its own

## Recalls of this device
- Jul 20, 2017 · Class II · Z-3118-2017: Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
- Jan 22, 2016 · Class II · Z-1171-2016: Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover

## Indications for use
For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

Source page: https://510kreport.com/device/K081938
Methodology: https://510kreport.com/methodology