510(k) · Cleared
ClearedLivesure Benzodiazepines Screen Tests
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pan Probe Biotech, Inc. · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on Jul 20, 2001 after an 11-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 20, 2001
- Review
- 11 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | EMIT® II Assay Named without a submission number |
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.
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 Pan Probe Biotech LiveSure™ Benzodiazepines Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for detection of Benzodiazepines drugs, analogs and metabolites (BZD) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 300 ng BZD/ml. The cut-off for both…
Read the full statement (205 words)
The Pan Probe Biotech LiveSure™ Benzodiazepines Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for detection of Benzodiazepines drugs, analogs and metabolites (BZD) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 300 ng BZD/ml. The cut-off for both LiveSure™ Test Card and Test Strip device methods has been set at 300 ng BZD drug/ml based upon calibration using Oxazepam as a prototype Benzodiazepine/BZD drug, and using Oxazepam standards with a GC/MS method for the quantitation of all the Oxazepam standard and urine test solutions. These IVD tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. Pan Probe Biotech LiveSure™ BZD Screen Tests for BZD provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
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/K012131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012131: Livesure Benzodiazepines Screen Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012131
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026