# K983699: Modification to Abuscreen Online for Amphetamines

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Dec 11, 1998 after 51 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
Longest line of descent: 1 generation back to K933052 (1993). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933052: Abuscreen Online (R) for Amphetamines, Modified, Roche Diagnostic Systems, Inc. (1993) Summary page 2.

## Most influential descendants
- K083764: Amphetamines II (2010), 1 descendant of its own
- K093664: Amphetamines II Assay (2010), 0 descendants of its own

## Indications for use
Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 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 amphetamine use or abuse.

Source page: https://510kreport.com/device/K983699
Methodology: https://510kreport.com/methodology