# K993988: Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029UL

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jan 27, 2000 after 64 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- 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; 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)
- None. The FDA summary names its predicate without a number.
- (no number) Emit® II Cocaine Metabolite Assay: named in the summary without a submission number

## Most influential descendants
- K031512: Emit II Plus Cocaine Metabolite Assay (2003), 4 descendants of its own
- K033713: Urine Cocaine Metabolite Screen Flex Reagent Cartridge, Catalog# DF92A (2004), 2 descendants of its own
- K062128: The Dimension Vista Flex Reagent Cartridges / Kit Assays (2006), 1 descendant of its own
- K170293: Emit II Plus Cocaine Metabolite Assay (2017), 0 descendants of its own
- K102045: Dimension Visa HBA1C, Model K3105A (2011), 0 descendants of its own

## Indications for use
The Emit® II Plus Cocaine Metabolite Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff (SAMSHA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Cocaine Metabolite 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 judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K993988
Methodology: https://510kreport.com/methodology