# K972891: Abuscreen Online for Amphetamines with Periodate - Olympus AU800/1000 Instrument Application

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Oct 1, 1997 after 57 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the qualitative and semi-quantitative detection of amphetamine and methamphetamine and their metabolites in human urine. Periodate may be used in conjunction with Abuscreen ONLINE for Amphetamines to minimize interference which may be caused by the presence of B-hydroxamine compounds in urine samples.

Source page: https://510kreport.com/device/K972891
Methodology: https://510kreport.com/methodology