# K033885: BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: May 19, 2004 after 156 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972526 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032764: Barbiturate Enzyme Immunoassay, CA. # 0140 (500 Tests Kit); Cat# 0141 (5000 Tests Kit), Lin-Zhi International, Inc. (2003) Summary page 2.
- K023317: Methadone Enzyme Immunoassay, Lin-Zhi International, Inc. (2002) Summary page 2.
- K032365: Benzodiazepine Enzyme Immunoassay, Lin-Zhi International, Inc. (2003) Summary page 2.
- K023795: Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit), Lin-Zhi International, Inc. (2003) Summary page 2.

## Indications for use
The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay. The assay is solely intended for use in the qualitative screening human urine samples for the presence of barbiturates, methadone, benzodiazepines, and propoxyphene drugs. . The assay will produce a positive result if any of the four analyte are present at a concentration at or above their respective cutoffs but will not identify which drug is present. The assay is solely intended for the qualitative screening of human urine for these analytes. Measurements obtained by this device are used in the diagnosis and treatment of individuals who have used barbiturates, methadone, benzodiazepines, and propoxyphene drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay provides only a preliminary analytical test result. The assay will not identify which drug is present in the positive urine sample. All screening positive samples shall subject to individual assays to identify the drug in the sample before alternative confirmation. Gas chromatography/mass spectrometry (GC/MS) 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/K033885
Methodology: https://510kreport.com/methodology