# K954291: Opus TDM Controls

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Nov 20, 1995 after 67 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- 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) BIO-RAD Lyphochek Immunoassay Plus TDM Control: named in the summary without a submission number

## Indications for use
OPUS TDM controls are intended for use as a quality control material to monitor the accuracy and precision of several OPUS immunoassays for which there are 510(k)’s. OPUS TDM Control have been evaluated for use with the following OPUS assays: Carbamazepine Digoxin Gentamicin Phenobarbital Phenytoin Theophylline Tobramycin Vancomycin Valproic Acid

Source page: https://510kreport.com/device/K954291
Methodology: https://510kreport.com/methodology