Fluorescent Immunoassay, Primidone
A fluorescent immunoassay for primidone is a laboratory diagnostic test used to measure serum primidone concentrations for therapeutic drug monitoring in patients receiving this anticonvulsant for the treatment of epilepsy. The device is FDA Class 2, representing moderate risk and requiring 510(k) premarket clearance before marketing. It carries product code LFT and is regulated under 21 CFR 862.3680 within the Clinical Toxicology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LFT
- Device Class
- FDA class 2
- Regulation Number
- 862.3680
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950028 | PRIMIDONE FPIA REAGENT SET AND CALIBRATORS | Mar 21, 1995 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K904683 | STRATUS PRIMIDONE FLUOROMETRIC ENZYME | Nov 28, 1990 | Substantially Equivalent | Baxter Healthcare Corp |
| K895567 | PRIMIDONE (FPIA) KIT | Oct 20, 1989 | Substantially Equivalent | Tudor Laboratories, Inc. |
| K852318 | COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS | Jun 25, 1985 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K842196 | STRATUS PRIMIDONE FLOROMETRIC ENZY | Jul 11, 1984 | Substantially Equivalent | American Dade |
| K823741 | ADVANCE EMIT-AED PRIMEDONE ASSAY | Jan 07, 1983 | Substantially Equivalent | Syva Co. |
| K822229 | PRIMIDONE FLUORESCENT IMMUNOASSAY | Aug 12, 1982 | Substantially Equivalent | American Diagnostic Corp. |
| K811007 | AMES TDA TM PRIMIDONE TEST | Apr 29, 1981 | Substantially Equivalent | Miles Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.