# K020794: Salicylate Assay for the Advia Integrated Modular System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Jul 11, 2002 after 122 days
- Product code: DKJ (Colorimetry, Salicylate)
- Device class: 2
- Regulation: 21 CFR 862.3830
- 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 K844070 (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)
- K844070: TDX Salicylate, Abbott Laboratories (1984) Summary page 2.

## Indications for use
The BayerADVLA UIS Salicylate methud is an in vilio diagno&c device intended to measure' salicylate levels in human serum or plasma (Lithium heparin). Such measurements are used in the'diagnosis of salicylate toxicity and overdose.

Source page: https://510kreport.com/device/K020794
Methodology: https://510kreport.com/methodology