# K983704: Modification to Abuscreen Online for Phencyclidine

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Feb 10, 1999 after 112 days
- Product code: JCM (Control, Hemoglobin, Abnormal)
- Device class: 2
- Regulation: 21 CFR 864.7415
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920935 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920935: Abuscreen Online for Phencyclidine, Roche Diagnostic Systems, Inc. (1992) Summary page 2.

## Most influential descendants
- K043305: Online Dat Phencyclidine Plus (2005), 0 descendants of its own

## Indications for use
Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on the Hitachi 917 analyzer at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of phencyclidine use or abuse.

Source page: https://510kreport.com/device/K983704
Methodology: https://510kreport.com/methodology