# JXM: Enzyme Immunoassay, Benzodiazepine

- Device class: 2; regulation: 21 CFR 862.3170; FDA's rule: 510(k) required
- FDA decisions: 90
- 510(k) review time 2021–2025: median 109 days (middle half 69–149)
- Recalls: 79 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 1
- 2011: 1
- 2012: 1
- 2015: 2
- 2016: 2
- 2017: 2
- 2018: 1
- 2019: 1
- 2022: 1
- 2024: 1

## Most-cited predicates
- K012300: Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test Device (2001), cited by 5
- K173963: DRI Benzodiazepine Assay (2018), cited by 2
- K993985: Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129UL (2000), cited by 2
- K111322: Chemtrue Single/Multi-Panel Drug Screen Cassette/Dipcard (2011), cited by 2
- K023048: Modification to Synchron Systems Benzodiazepine Reagent (2002), cited by 2
- K910590: Abuscreen Ontrak for Benzodiazepine (1991), cited by 2
- K930529: Benzodiazepine Enzyme Immunoassay (1993), cited by 2
- K914509: Abuscreen (R) Online (TM) for Benzodiazepines (1991), cited by 2
- K962734: Cedia Dau Benzodiazepine Assay (1996), cited by 1
- K123080: Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette Tests (2012), cited by 1

Source page: https://510kreport.com/product-code/JXM
Data by year (CSV): https://510kreport.com/product-code/JXM.csv