# K031512: Emit II Plus Cocaine Metabolite Assay

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 23, 2003 after 70 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
Longest line of descent: 1 generation back to K993988 (2000). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993988: Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029UL, Syva Co. (2000) Summary page 1.

## Most influential descendants
- 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
- K102045: Dimension Visa HBA1C, Model K3105A (2011), 0 descendants of its own
- K062123: Vitros Chemistry Products Cocm Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat Performance Verifiers I, II, Iii, IV (2006), 0 descendants of its own

## Indications for use
The Emit II Plus Cocaine Metabolite Assay is a homogeneous 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 Monoclonal 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 judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K031512
Methodology: https://510kreport.com/methodology