510(k) · Cleared
ClearedRapidone- Benzodiazepine Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bio Medica Corp. · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on Apr 3, 2000 after a 234-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Apr 3, 2000
- Review
- 234 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K990099 | Instacheck Drug Screen — Benzodiazepine Test Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ments of 21 CFR 807.92. The assigned 510(k) number is: Ka 42720 Predicate Device: Forefront Diagnostics, Inc. ‘Instacheck® Drug Screen — Benzodiazepine Test (510(k) No.K990099.) Test Description: The assay employed in the ‘RapidOne’- Benzodiazepine Test is based on the same principle of highly specific… |
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?
'RapidOne’ - Benzodiazepine Test is a one-step, lateral flow immunoassay for the detection of Benzodiazepine in urine. ‘RapidOne’ - Benzodiazepine Test is intended for use in the qualitative detection of oxazepam in human urine at 300 ng/ml. ‘RapidOne’ - Benzodiazepine Test is intended for professional use. It is not intended for over the counter sale to non-professionals. The assay is easy to perform, but should not be used without proper supervision.…
Read the full statement (159 words)
'RapidOne’ - Benzodiazepine Test is a one-step, lateral flow immunoassay for the detection of Benzodiazepine in urine. ‘RapidOne’ - Benzodiazepine Test is intended for use in the qualitative detection of oxazepam in human urine at 300 ng/ml.
‘RapidOne’ - Benzodiazepine Test is intended for professional use. It is not intended for over the counter sale to non-professionals. The assay is easy to perform, but should not be used without proper supervision.
This immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).
‘RapidOne’ - Benzodiazepine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical 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/K992720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992720: Rapidone- Benzodiazepine Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992720
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026