Abuscreen Radioummunoassay--Urine

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K830462 ↗

FDA Product Code

DOE

Device Class

Class II

Regulation

21 CFR Part 862.3640

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Hoffmann-La Roche, Inc. →

• What is the Abuscreen Radioimmunoassay—Urine used for?

  This device detects and quantifies morphine in urine samples through a radioimmunoassay process. It uses a 125-I labeled morphine and a goat antibody separation system to measure morphine levels accurately, supporting clinical toxicology assessments such as drug monitoring or overdose investigations. The quantitative results help clinicians assess exposure and guide treatment decisions.

• How is the Abuscreen Radioimmunoassay—Urine supplied and prepared?

  The kit is supplied as a single-use diagnostic tool, requiring sterile urine sample preparation in a laboratory setting. Users must follow radioactive material safety protocols during handling, as the assay relies on 125-I labeling. Proper aseptic techniques and compliance with radioactive waste regulations are essential to ensure accurate results and safety.

• Is the device sterile and intended for single-use?

  Yes, the Abuscreen Radioimmunoassay—Urine is designed for single-use only. The kit components are intended to be used once per test to maintain sterility and accuracy. Reuse is not recommended due to potential contamination risks and degradation of radioactive labeling over time.

• What storage and handling precautions must be followed?

  Storage and use must comply with radioactive material regulations, as the device contains 125-I labeling. It should be stored in a secure, locked area with restricted access, following manufacturer guidelines for radioactive waste disposal. Proper shielding and monitoring equipment may be required during handling to minimize exposure risks.

• What regulatory pathway was used for clearance, and what class does it fall under?

  The device was cleared via a Traditional 510(k) pathway by the FDA’s Clinical Toxicology Advisory Committee, with a Substantially Equivalent determination. It is classified as a Class II medical device, indicating moderate risk and requiring compliance with specific regulatory controls to ensure safety and effectiveness.