# K100200: Advia Chemistry Acetaminophen Reagent, Model Ref 07989138

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Aug 2, 2010 after 189 days
- Product code: LDP (Colorimetry, Acetaminophen)
- Device class: 2
- Regulation: 21 CFR 862.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Jun 30, 2015 · Class II · Z-2416-2015: A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots.

## Indications for use
For in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems. Such measurements are used in the detection of acetaminophen overdose.

Source page: https://510kreport.com/device/K100200
Methodology: https://510kreport.com/methodology