# K011878: Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators, Model 7S109UL

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Aug 13, 2001 after 59 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 K951290 (1995). 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)
- K951290: Axsym Salicylate, Abbott Laboratories (1995) Summary page 1.

## Indications for use
The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme immunoassay intended for use in the quantitative analysis of salicylic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of salicylic acid overdose or in manitoring levels of salicylic acid to ensure appropriate therapy.

Source page: https://510kreport.com/device/K011878
Methodology: https://510kreport.com/methodology