Fluorescent Immunoassay, Theophylline
The Fluorescent Immunoassay for Theophylline is a laboratory diagnostic test used to quantitatively measure theophylline levels in patient specimens, supporting therapeutic drug monitoring for conditions such as asthma and chronic obstructive pulmonary disease. The device is FDA Class 2, indicating moderate risk; it requires 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. It carries product code LER and is regulated under 21 CFR 862.3880 in the Clinical Toxicology specialty. This device is eligible for third-party review under FDA's accredited persons program.
Research product code LER in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- LER
- 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 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K942192 | THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS | Jul 13, 1994 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K905521 | CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION | Dec 26, 1990 | Substantially Equivalent | Microgenics Corp. |
| K882570 | TURBOX THEOPHYLLINE ASSAY | Nov 10, 1988 | Substantially Equivalent | Unipath , Ltd. |
| K864409 | IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS | Dec 22, 1986 | Substantially Equivalent | Sclavo, Inc. |
| K863475 | THEOFAST(TM) TEST PACKAGE | Nov 05, 1986 | Substantially Equivalent | 3M Company |
| K842585 | THEOPHYLLINE KIT FLUORESCENCE POLARIZA- | Sep 26, 1984 | Substantially Equivalent | Windsor Laboratories, Inc. |
| K840758 | IMMPULSE THEOPHYLLINE ASSAY REAGENTS | Apr 04, 1984 | Substantially Equivalent | Paragon Diagnostics, Inc. |
| K833070 | TDX THEOPHYLLINE | Nov 14, 1983 | Substantially Equivalent | Abbott Laboratories |
| K831514 | AMWA TDA THEOPHYLLINE TEST | Jun 30, 1983 | Substantially Equivalent | Miles Laboratories, Inc. |
| K823576 | COBAS STANDARD FOR TOTAL PROTEIN | Jan 07, 1983 | Substantially Equivalent | Hoffmann-La Roche, Inc. |
| K820397 | AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM | Mar 02, 1982 | Substantially Equivalent | American Diagnostic Corp. |
| K813240 | EMIT-AAD THEOPHYLLINE ASSAY | Dec 03, 1981 | Substantially Equivalent | Syva Co. |
| K812518 | AMES TDA THEOPHYLLINE TEST | Sep 23, 1981 | Substantially Equivalent | Miles Laboratories, Inc. |
| K811856 | FLUOROMATIC THEOPHYLLINE FIA | Jul 10, 1981 | Substantially Equivalent | Bio-Rad |
| K810943 | AMES TDA THEOPHYLLINE TEST | Apr 17, 1981 | Substantially Equivalent | Miles Laboratories, Inc. |