EMIT-AAD Theophylline Assay
by Syva Co. 510(k)
Active
510(k) K813240
Overview
The EMIT-AAD Theophylline Assay is a fluorescent immunoassay device used for the quantitative determination of theophylline in human serum or plasma. This device is designed to measure theophylline levels, which is a medication used to treat respiratory diseases such as asthma and COPD. The assay provides accurate and reliable results for therapeutic drug monitoring.
The EMIT-AAD Theophylline Assay is supplied as a single-use device and requires appropriate laboratory equipment for operation. It is stored under conditions specified by the manufacturer and is intended for professional use in clinical settings. The device has received FDA 510(k) clearance with the product code LER and is classified as Class II under regulation number 862.3880.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813240 | Date3 Dec 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LER
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3880
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the EMIT-AAD Theophylline Assay used for?
The EMIT-AAD Theophylline Assay is a fluorescent immunoassay device used for the quantitative determination of theophylline in human serum or plasma. It helps healthcare professionals monitor theophylline levels, which is a medication used to treat respiratory diseases such as asthma and COPD.
How is the EMIT-AAD Theophylline Assay supplied?
The EMIT-AAD Theophylline Assay is supplied as a single-use device and requires appropriate laboratory equipment for operation. It is intended for professional use in clinical settings and should be stored under conditions specified by the manufacturer.
What is the regulatory status of the EMIT-AAD Theophylline Assay?
The EMIT-AAD Theophylline Assay has received FDA 510(k) clearance with the product code LER and is classified as Class II under regulation number 862.3880. It was determined to be substantially equivalent to other marketed devices.
What medical specialty is associated with the EMIT-AAD Theophylline Assay?
The EMIT-AAD Theophylline Assay is associated with Clinical Toxicology as indicated by its review advisory committee. This reflects its application in monitoring therapeutic drug levels for medications used in treating respiratory conditions.