Coat-A-Count Theophylline

No FDA recalls found in the data synced 5 Oct 2026.

Full name

Coat-A-Count (Tm) Theophylline

510(k) Number

K890002 ↗

FDA Product Code

KLS

Device Class

Class II

Regulation

21 CFR Part 862.3880

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Diagnostic Products Corp. →

• What is the Coat-A-Count Theophylline used for?

  This device is designed for the quantitative measurement of theophylline in biological samples, such as blood or serum. Theophylline monitoring is critical for managing patients with conditions like asthma or chronic obstructive pulmonary disease (COPD) who are undergoing theophylline therapy. Accurate measurement helps clinicians adjust dosages to maintain therapeutic levels and avoid toxicity.

• How is the Coat-A-Count Theophylline supplied, and is it single-use?

  The Coat-A-Count Theophylline is supplied as a kit for in vitro diagnostic use. Each kit is intended for single-use only, meaning it should not be reused after opening or testing. This ensures accuracy and sterility for each assay, as reuse could compromise results or introduce contamination.

• What storage requirements does the kit have?

  The kit requires proper storage as outlined in the accompanying instructions. While the exact storage conditions (e.g., temperature, humidity) are not detailed here, typical enzyme immunoassay kits like this one are generally stored refrigerated (2–8°C) and protected from light until use. Always refer to the included instructions for precise storage guidelines to maintain assay validity.

• Is the Coat-A-Count Theophylline sterile, and how does that affect its use?

  The kit is designed for in vitro diagnostic use and is intended to be used under controlled clinical conditions. Sterility is implied for the components within the kit (e.g., reagents, conjugates) to prevent contamination during testing. However, the user must follow aseptic techniques when handling samples and reagents to avoid introducing external contaminants, which could affect assay accuracy.

• What regulatory pathway does this device follow, and who should use it?

  The Coat-A-Count Theophylline is classified as a Class II medical device under FDA regulation 862.3880 and has received FDA 510(k) clearance (K890002), confirming it is substantially equivalent to a predicate device. It is intended for use in clinical toxicology settings, such as hospitals or laboratories, by trained healthcare professionals or technicians experienced in enzyme immunoassay techniques and theophylline monitoring.