# K974029: Acs Tobramycin

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Feb 12, 1998 after 112 days
- Product code: LCR (Fluorescent Immunoassay, Tobramycin)
- Device class: 2
- Regulation: 21 CFR 862.3900
- 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) TDX/FLx Tobramycin Immunoassay: named in the summary without a submission number

## Indications for use
The Chiron Diagnostics ACS:180 Tobramycin Assay is for the quantitative determination of tobramycin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence Systems. Monitoring the patient's serum or plasma tobramycin levels is important both to ensure that the drug is present in therapeutic concentrations and to avoid toxicity.

Source page: https://510kreport.com/device/K974029
Methodology: https://510kreport.com/methodology