510(k) · Cleared
ClearedSyva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129UL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syva Co. · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on Jan 27, 2000 after a 64-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jan 27, 2000
- Review
- 64 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK993985 Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129ULSyva Co. · 2000
- Descendant · cites it directly · 1 of its ownK032365 Benzodiazepine Enzyme ImmunoassayLin-Zhi International, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK062285 Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS…Ortho-Clinical Diagnostics, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK033885 BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See all- K032365Benzodiazepine Enzyme ImmunoassayLin-Zhi International, Inc. · 2003 · cites it directly1descendant
- K062285Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat…Ortho-Clinical Diagnostics, Inc. · 2006 · cites it directly0descendants
- K033885BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993985 | Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129UL | Syva Co. | 2000 | — |
| +1 | K032365 | Benzodiazepine Enzyme Immunoassay | Lin-Zhi International, Inc. | 2003 | — |
| +1 | K062285 | Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS Calibrator 1 and… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
| +2 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | — | Syva Emit® II Benzodiazepine Assay Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K032365 (Lin-Zhi International, Inc., 2003) has gone furthest, with 1 descendant of its own.
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 Syva Emit® II Plus Benzodiazepine Assay is a homogeneous enzyme immunoassay with a 200 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzodiazepines in human urine. Syva Emit® II Plus assays are designed for use with a number of chemistry analyzers. The Syva Emit® II Plus Benzodiazepine Assay provides only a preliminary analytical test resuilt. A more specific alternative chemical method…
Read the full statement (116 words)
The Syva Emit® II Plus Benzodiazepine Assay is a homogeneous enzyme immunoassay with a 200 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzodiazepines in human urine. Syva Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Syva Emit® II Plus Benzodiazepine Assay provides only a preliminary analytical test resuilt. 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. Other chemical confirmation methods are available. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993985: Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129UL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993985
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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