# K993983: Syva Emit II Plus Phencyclidine Assay, Model 9J029UL

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jan 27, 2000 after 64 days
- Product code: LCM (Enzyme Immunoassay, Phencyclidine)
- Device class: U
- 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 Phencyclidine Assay: named in the summary without a submission number

## Most influential descendants
- K062094: Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat Performance Verifiers I, II, Iii, IV, & V (2006), 0 descendants of its own

## Indications for use
The Emit® II Plus Phencyclidine Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 25 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of phencyclidine in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Phencyclidine 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/K993983
Methodology: https://510kreport.com/methodology