# K083764: Amphetamines II

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Feb 3, 2010 after 412 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: 2 generations back to K933052 (1993). 2 ancestors in all.
1 later device descends 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)
- K983699: Modification to Abuscreen Online for Amphetamines, Roche Diagnostic Systems, Inc. (1998) Summary page 3.

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

## Indications for use
Amphetamines 1I (AMP1I) is an in vitro diagnostic test for the qualitative and semniquantitative detection of amphetamines and methamphetarnines on automated clinical chemistry analyzers at cutoff concentrations of 300 ng/mL, 500 ng/mL and 1 000 ng/mnL when calibrated with d-inethamphetarnine. Semniquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Serniquarititative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromnatography/mass spectrometry (GC/MS). Amphetamines II provides only a preliminary analytical test result. A more specific alternate chemical method must he used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.) Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K083764
Methodology: https://510kreport.com/methodology