# K993985: Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129UL

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jan 27, 2000 after 64 days
- Product code: JXM (Enzyme Immunoassay, Benzodiazepine)
- Device class: 2
- Regulation: 21 CFR 862.3170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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) Syva Emit® II Benzodiazepine Assay: named in the summary without a submission number

## Most influential descendants
- K032365: Benzodiazepine Enzyme Immunoassay (2003), 1 descendant of its own
- K062285: Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat Performance Verifiers I, II, Iii, IV (2006), 0 descendants of its own
- K033885: BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) (2004), 0 descendants of its own

## Indications for use
The Syva Emit® II Plus Benzodiazepine Assay is a homogeneous enzyme immunoassay with a 200 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzodiazepines in human urine. Syva Emit® II Plus assays are designed for use with a number of chemistry analyzers. The Syva Emit® II Plus Benzodiazepine Assay provides only a preliminary analytical test resuilt. 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/K993985
Methodology: https://510kreport.com/methodology