# K964587: Vancomycin Assay or the Technicon Immuno 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jan 13, 1997 after 59 days
- Product code: LEH (Radioimmunoassay, Vancomycin)
- Device class: 2
- Regulation: 21 CFR 862.3950
- Recalls of this device: none
- 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 its predicate without a number.
- (no number) Syva EMIT® Vancomycin Assay: named in the summary without a submission number

## Indications for use
This in vitro method is intended to quantitatively measure vancomycin, an antibiotic, in human serum or plasma (heparin) using Syva EMIT® Vancomycin Assay on a Technicon Immuno-1® system. Measurements of vancomycin are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K964587
Methodology: https://510kreport.com/methodology