Modification to Abuscreen Online for Phencyclidine

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K983704 ↗

FDA Product Code

JCM

Device Class

Class II

Regulation

21 CFR Part 864.7415

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Roche Diagnostic Systems, Inc. →

• What is the intended use of the Modification to Abuscreen Online for Phencyclidine device?

  This device is an in vitro diagnostic immunoassay designed to detect phencyclidine and its metabolites in human urine samples. It is used on the Hitachi 917 automated clinical chemistry analyzer to measure changes in light transmission resulting from the kinetic interaction of microparticles in solution, which indicates the presence of the target analyte.

• How is the Modification to Abuscreen Online for Phencyclidine supplied and what equipment is required for its use?

  The device is supplied as a reagent kit intended for use exclusively with the Hitachi 917 automated clinical chemistry analyzer. It requires this specific analyzer to perform the immunoassay, as the measurement principle relies on the analyzer's ability to detect changes in light transmission from microparticle interactions in solution.

• What regulatory pathway was used for the clearance of the Modification to Abuscreen Online for Phencyclidine device?

  The device received traditional 510(k) clearance from the FDA under submission number K983704, which was granted on February 10, 1999. It was determined to be substantially equivalent to a legally marketed predicate device, which is the basis for its clearance under the 510(k) pathway.

• What is the device classification and regulation number for the Modification to Abuscreen Online for Phencyclidine?

  The device is classified as FDA Class 2 and is regulated under 21 CFR 864.7415, which covers immunoassays for drugs of abuse. This classification reflects its risk level and the general controls plus special controls required to ensure its safety and effectiveness.

• Is the Modification to Abuscreen Online for Phencyclidine a reusable or single-use device?

  The device is supplied as a reagent for in vitro diagnostic use and is intended for single-use testing runs on the Hitachi 917 analyzer. Reagents are consumed during the assay process and are not designed for reuse, as each test requires fresh reagent to ensure accurate detection of phencyclidine and metabolites in urine.