# K020792: Acetaminophen Assay for the Advia Integrated Modular System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Jul 11, 2002 after 122 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: 1 generation back to K840941 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840941: TDX Acetaminophen, Abbott Laboratories (1984) Summary page 2.

## Indications for use
The Buyer ADC24 M S Acetaminophen method 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.

Source page: https://510kreport.com/device/K020792
Methodology: https://510kreport.com/methodology