Opus Phenytoin Test System
by Pb Diagnostic Systems, Inc.
510(k) K896868
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896868 | Date2 Jan 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LGR
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3350
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Opus Phenytoin Test System is a fluorescence polarization immunoassay device used for the quantitative determination of diphenylhydantoin (total phenytoin) in human serum and plasma. This device is classified under clinical toxicology and is designed to measure phenytoin levels, which is important for therapeutic drug monitoring.
The system is supplied as a single-use device and is not indicated for MRI compatibility. It is stored according to manufacturer specifications and has received FDA 510(k) clearance with the product code LGR. The device is authorized for use in clinical toxicology settings and has been cleared for the detection of total phenytoin concentrations in patient samples.
Other devices from Pb Diagnostic Systems, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the OPUS Phenytoin Test System used for?
The OPUS Phenytoin Test System is used for the quantitative determination of diphenylhydantoin (total phenytoin) in human serum and plasma, which is important for therapeutic drug monitoring in clinical toxicology settings.
How is the OPUS Phenytoin Test System supplied and is it reusable?
The system is supplied as a single-use device and is not designed for reuse; it is intended for one-time application in clinical testing to ensure accurate phenytoin level measurement.
What type of technology does the OPUS Phenytoin Test System use?
The device uses fluorescence polarization immunoassay technology to quantitatively detect total phenytoin concentrations in patient samples, enabling precise therapeutic drug monitoring.