Fluorescence Polarization Immunoassay, Theophylline
A fluorescence polarization immunoassay for theophylline is a laboratory test that measures serum or plasma theophylline concentrations using polarized fluorescence principles, used for therapeutic drug monitoring in patients receiving theophylline for asthma or chronic obstructive pulmonary disease. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. It carries product code LGS and is regulated under 21 CFR 862.3880 within the Clinical Toxicology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LGS
- Device Class
- FDA class 2
- Regulation Number
- 862.3880
- 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 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070810 | ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) | Jun 08, 2007 | Substantially Equivalent | Biokit, S.A. |
| K955567 | INNOFLUOR THEOPHYLLINE ASSAY SYSTEM | Jan 24, 1996 | Substantially Equivalent | Oxis Intl., Inc. |
| K953016 | AXSYM THEOPHYLLINE II | Aug 24, 1995 | Substantially Equivalent | Abbott Laboratories |
| K951169 | CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY | Jun 20, 1995 | Substantially Equivalent | Ciba Corning Diagnostics Corp. |
| K942991 | QMS THEOPHYLLINE CS | Sep 09, 1994 | Substantially Equivalent | Seradyn, Inc. |
| K932127 | TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II | Aug 09, 1993 | Substantially Equivalent | Abbott Laboratories |
| K922991 | ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE | Aug 27, 1992 | Substantially Equivalent | Abbott Laboratories |
| K900706 | MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA | Apr 12, 1990 | Substantially Equivalent | Innotron of Oregon, Inc. |
| K894529 | FPR THEOPHYLLINE KIT | Sep 15, 1989 | Substantially Equivalent | Colony Laboratories, Inc. |
| K871484 | COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS | May 28, 1987 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K870277 | MONITORX LASERX THEOPHYLLINE REAGENT SET | Feb 18, 1987 | Substantially Equivalent | American Monitor Corp. |
| K850629 | INNOFLUOR THEOPHYLLINE | Mar 12, 1985 | Substantially Equivalent | Innotron Diagnostics |
| K843826 | COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL | Feb 01, 1985 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.