# K031004: Syva Emit II Plus Amphetamines Assay

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jun 6, 2003 after 67 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 K993982 (2000). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993982: Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129UL, Syva Co. (2000) Summary page 1.

## Most influential descendants
- K040133: Urine Amphetamine/Methamphetamine Screen Flex Reagent Cartridge (2004), 2 descendants of its own
- K062077: Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers (2006), 1 descendant of its own
- K062128: The Dimension Vista Flex Reagent Cartridges / Kit Assays (2006), 1 descendant of its own
- K143500: Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set (2015), 0 descendants of its own
- K102045: Dimension Visa HBA1C, Model K3105A (2011), 0 descendants of its own

## Indications for use
The Emit II Plus Amphetamines Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff, 500 ng/mL cutoff or a 1000 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine. Emit II Plus assays are designed for use with a number of chemistry analyzers. The Emit II Plus Amphetamines 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 (GCMS) 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/K031004
Methodology: https://510kreport.com/methodology