510(k) · Cleared
ClearedBenzodiazepine Enzyme Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on Sep 5, 2003 as substantially equivalent to K993985 (Syva Co., 2000) after a 36-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Sep 5, 2003
- Review
- 36 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993985 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK993985 Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129ULSyva Co. · 2000
- This deviceK032365 Benzodiazepine Enzyme ImmunoassayLin-Zhi International, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK033885 BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K033885BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993985 | Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129UL | Syva Co. | 2000 | — |
| 0 (this device) | K032365 | Benzodiazepine Enzyme Immunoassay | Lin-Zhi International, Inc. | 2003 | — |
| +1 | K033885 | BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) | Lin-Zhi International, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 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 JXM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JXM device
- #1 K243498 Alinity c Benzodiazepines Reagent Kitscore 8.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K993985 | Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129ULSummary page 1…epine Enzyme Immunoassay is substantially equivalent to Syva EMIT@ I1 Plus Benzodiazepine Assay (By Syva Company-Dade Behring Inc.), cleared under premarket notification K993985. LZI’s Benzodiazepine Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, de… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033885 | BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) | 2004 | 0 |
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?
How does its category compare?
All JXM devicesJXM Enzyme Immunoassay, Benzodiazepine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JXM
Too few JXM 510(k)s in any year since 2007 to give a median.
Recalls per year · JXM
79in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXM
6in 2025
MAUDE reports naming product code JXM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 79 | 5 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Benzodiazepine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of benzodiazepines in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Benzodiazepine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical…
Read the full statement (161 words)
The Benzodiazepine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of benzodiazepines in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Benzodiazepine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order 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 the preliminary positive results are used.
The Benzodiazepine Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Benzodiazepine enzyme immunoassay to detect benzodiazepines in human urine.
The Benzodiazepine Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Benzodiazepine enzyme immunoassay to detect benzodiazepines in human urine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032365 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032365: Benzodiazepine Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032365
Report an extraction error
Are you the manufacturer?
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