Abuscreen Radioimmunoassay for Amphetamine

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

510(k) Number

K912755 ↗

FDA Product Code

DJP

Device Class

Class II

Regulation

21 CFR Part 862.3100

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Abuscreen(R) Radioimmun for Cocaine Metabolite

  Class II

  FDA 510(k) K913722 Active Cleared 10 Sep 1991

• Cobas Core Immunochemistry System

  Class I

  FDA 510(k) K962231 Active Cleared 30 Aug 1996

• Roche Reagent for Apolipoprotein B

  Class I

  FDA 510(k) K910552 Active Cleared 7 May 1991

• Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P

  Class II

  FDA 510(k) K952337 Active Cleared 9 Feb 1996

• Roche Abuscreen Ontrak Pos. Ref. Control-Methadone

  Class I

  FDA 510(k) K930844 Active Cleared 27 Jan 1994

• Ontrak Testcup Amphetamines

  Class II

  FDA 510(k) K962411 Active Cleared 7 Oct 1996

See all devices from Roche Diagnostic Systems, Inc. →

• What is the Abuscreen Radioimmunoassay for Amphetamine used for?

  This device is designed to detect and quantify amphetamine in biological specimens, such as urine or serum, to aid in identifying amphetamine abuse or exposure. It is specifically intended for use in clinical toxicology laboratories to support substance abuse monitoring and diagnostic testing.

• How is the Abuscreen Radioimmunoassay for Amphetamine supplied?

  The device is supplied as a kit for laboratory use. Each kit is intended for single-use, meaning it should not be reused after one assay. Proper handling and adherence to radiation safety protocols are required due to the radioactive components involved in the assay process.

• Does this device require special storage conditions?

  Yes, the assay must be stored under controlled conditions to maintain stability and ensure accurate results. Since it contains radioactive materials, storage should also comply with radiation safety regulations to protect personnel and the environment.

• Is the Abuscreen Radioimmunoassay for Amphetamine reusable?

  No, the device is intended for single-use only. Each kit is designed for one assay, and reuse is not recommended or supported by the manufacturer to maintain accuracy and safety, particularly given the radioactive labeling involved.

• What regulatory clearance does this device hold?

  The Abuscreen Radioimmunoassay for Amphetamine holds FDA 510(k) clearance under the reference number K912755. This clearance indicates that the device is classified as substantially equivalent to a legally marketed predicate device and is regulated under the FDA’s clinical toxicology category.