510(k) · Cleared
ClearedBMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DIS Enzyme Immunoassay, Barbiturate
Cleared on May 19, 2004 as substantially equivalent to K032764 (Lin-Zhi International, Inc., 2003) and 3 other predicates after a 156-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- May 19, 2004
- Review
- 156 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K972526 (1997). 9 ancestors in all, the oldest K935101 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972526 | Methadone Eia Assay | Diagnostic Reagents, Inc. | 1997 | — |
| −1 | K023317 | Methadone Enzyme Immunoassay | Lin-Zhi International, Inc. | 2002 | — |
| 0 (this device) | K033885 | BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) | Lin-Zhi International, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032764 | Barbiturate Enzyme Immunoassay, CA. # 0140 (500 Tests Kit); Cat# 0141 (5000 Tests Kit)Summary page 2…ethadone Enzyme Immunoassay, Benzodiazepine Enzyme Immunoassay, and Propoxyphene Enzyme Immunoassay by Lin- Zhi International, Inc., cleared under premarket notification K032764 (Barbiturate Enzyme Immunoassay), K023317 (Methadone Enzyme Immunoassay), K032365 (Benzodiazepine Enzyme Immunoassay), and K02379… | 2003 |
| * | K023317 | Methadone Enzyme ImmunoassaySummary page 2…e Enzyme Immunoassay, and Propoxyphene Enzyme Immunoassay by Lin- Zhi International, Inc., cleared under premarket notification K032764 (Barbiturate Enzyme Immunoassay), K023317 (Methadone Enzyme Immunoassay), K032365 (Benzodiazepine Enzyme Immunoassay), and K023795 (Propoxyphene Enzyme Immunoassay). LZI'… | 2002 |
| * | K032365 | Benzodiazepine Enzyme ImmunoassaySummary page 2…nzyme Immunoassay by Lin- Zhi International, Inc., cleared under premarket notification K032764 (Barbiturate Enzyme Immunoassay), K023317 (Methadone Enzyme Immunoassay), K032365 (Benzodiazepine Enzyme Immunoassay), and K023795 (Propoxyphene Enzyme Immunoassay). LZI's Simultaneous Barbiturate-Methadone-Ben… | 2003 |
| * | K023795 | Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit)Summary page 2…, cleared under premarket notification K032764 (Barbiturate Enzyme Immunoassay), K023317 (Methadone Enzyme Immunoassay), K032365 (Benzodiazepine Enzyme Immunoassay), and K023795 (Propoxyphene Enzyme Immunoassay). LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIS
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIS
1in 2018
MAUDE reports naming product code DIS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 331 | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 29 | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (199 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033885 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033885: BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033885
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026