Nephelometric Inhibition Immunoassay, Phenobarbital
A nephelometric inhibition immunoassay for phenobarbital is a laboratory test that uses light-scattering measurement principles to quantify phenobarbital concentrations in patient specimens, supporting therapeutic drug monitoring in patients on anticonvulsant therapy. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. It carries product code LFN and is regulated under 21 CFR 862.3660 within the Clinical Toxicology specialty. This device is eligible for third-party review.
Basic Information
- Product Code
- LFN
- Device Class
- FDA class 2
- Regulation Number
- 862.3660
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934388 | QMS PHENOBARBITAL | Feb 25, 1994 | Substantially Equivalent | Seradyn, Inc. |
| K864612 | DART PHENOBARBITAL ASSAY SYSTEM | Jan 13, 1987 | Substantially Equivalent | Coulter Electronics, Inc. |
| K860304 | DUPONT PHENOBARBITAL ASSAY | Feb 28, 1986 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K860303 | DUPONT PHENOBARBITAL CALIBRATOR | Feb 28, 1986 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K821543 | IPA FOR DETECTION OF PHENOBARBITAL | Jun 03, 1982 | Substantially Equivalent | Electro-Nucleonics Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.