# K012257: Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229

- Pathway: 510(k) (Special)
- Applicant: Syva Co.
- Decided: Aug 3, 2001 after 16 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. The FDA summary names its predicate without a number.
- (no number) Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay: named in the summary without a submission number

## Indications for use
The Emit® Il Plus Monoclonal Amphetamine/Methamphetamine Assay is a homogeneous enzyme immunoassay with a 1000 ng/mi cutoff (SAMHSA initial test cutoff level). The ass;y is intended for use in the qualitative and semi-quantitative analysis of amphetamines in human urine. These reagents are packaged specifically for use on a variety of Olympus® analyzers. The Emit® Il Plus Monoclonal Amphetamine/Methamphetamine Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. 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/K012257
Methodology: https://510kreport.com/methodology