# K032764: Barbiturate Enzyme Immunoassay, CA. # 0140 (500 Tests Kit); Cat# 0141 (5000 Tests Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Nov 3, 2003 after 59 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935101 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K010934: Emit II Plus Barbituate Assay, Model 0SR9D0229, Syva Co., Dade Behring, Inc. (2001)
- K935101: Urine Calibrators and Controls Modification, Diagnostic Reagents, Inc. (1994) Summary page 6.

## Most influential descendants
- K033885: BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) (2004), 0 descendants of its own

## Recalls of this device
- Sep 8, 2011 · Not classified · Z-0846-2012: Catalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correctly aligned.

## Indications for use
The Barbiturate Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine. The Barbiturate Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine. The Barbiturate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semi-quantitative analyses of barbiturates in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy. The Barbiturate Enzyme Immunoassay 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 (GCMS) is the preferred confirmatory method. 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/K032764
Methodology: https://510kreport.com/methodology