# K042330: Acetaminophen-SL Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Jan 7, 2005 after 133 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
No predicates in its family tree.
3 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K081938: Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30 (2009), 2 descendants of its own
- K202644: Acetaminophen (2022), 0 descendants of its own
- K180835: SEKURE Acetaminophen L3K Assay (2019), 0 descendants of its own

## Recalls of this device
- May 29, 2012 · Class II · Z-1902-2012: Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
- Jun 1, 2007 · Not classified · Z-1233-2007: Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000.

## Indications for use
The Diagnostic Chemicals Limited's Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose. This assay consists of two reagents and a calibrator.

Source page: https://510kreport.com/device/K042330
Methodology: https://510kreport.com/methodology