# K994005: Syva Emit II Plus Methadone Assay, Models 9E029UL/9E129UL

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jan 20, 2000 after 57 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- 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) Syva Emit® II Methadone Assay: named in the summary without a submission number

## Indications for use
The Emit® II Plus Methadone Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of methadone in human urine. The Emit® II Plus assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Methadone 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/K994005
Methodology: https://510kreport.com/methodology