# K993982: Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129UL

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jan 27, 2000 after 64 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Syva Emit® II Monoclonal Amphetamine/Methamphetamine Assay: named in the summary without a submission number

## Most influential descendants
- K031004: Syva Emit II Plus Amphetamines Assay (2003), 5 descendants of its own
- 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

## Indications for use
The Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay is a homogeneous drugs-of-abuse enzyme immunoassay with 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 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/K993982
Methodology: https://510kreport.com/methodology