# K993984: Syva Emit II Plus Cannabinoid Assay, Models 9N029UL/9N129UL

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jan 18, 2000 after 55 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 Cannabinoid 20 ng Assay: named in the summary without a submission number
- (no number) Emit® II Cannabinoid 50 ng Assay: named in the summary without a submission number
- (no number) Emit® II Cannabinoid 100 ng Assay: named in the summary without a submission number

## Most influential descendants
- K063164: Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat Performance Verifiers I, II, Iii, IV (2006), 0 descendants of its own

## Indications for use
The Emit® II Plus Cannabinoid Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 20 ng/mL, 50 ng/mL (SAMHSA initial test cutoff level), or 100 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of cannabinoids in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

Source page: https://510kreport.com/device/K993984
Methodology: https://510kreport.com/methodology