# K993987: Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129UL

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jan 27, 2000 after 64 days
- Product code: KLT (Enzyme Immunoassay, Carbamazepine)
- Device class: 2
- Regulation: 21 CFR 862.3645
- 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 Barbiturate Assay: named in the summary without a submission number

## Most influential descendants
- K062165: Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers (2007), 0 descendants of its own

## Indications for use
The Emit® II Plus Barbiturate Assay is a drugs-of-abuse homogeneous enzyme immunoassay intended for use in the qualitative and semiquantitative analysis of barbiturates in the human urine. Emit® II assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Barbiturate 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.

Source page: https://510kreport.com/device/K993987
Methodology: https://510kreport.com/methodology