# DJC: Thin Layer Chromatography, Methamphetamine

- Device class: 2; regulation: 21 CFR 862.3610; FDA's rule: 510(k) required
- FDA decisions: 31
- 510(k) review time 2021–2025: median 411 days (middle half 411–411)
- Recalls: 0 (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)
- 2001: 2
- 2002: 3
- 2003: 2
- 2006: 3
- 2008: 1
- 2013: 1
- 2016: 1
- 2018: 3
- 2025: 1
- 2026: 1

## Most-cited predicates
- K060896: Modification to Ontrak Testcup II and Onsite Cupkit (2006), cited by 2
- K171403: OralTox Oral Fluid Drug Test (2018), cited by 2
- K022501: Instant-View Mdma (Ecstasy, XTC) Urine Test (2002), cited by 1
- K011185: Psychemedics Ria Methamphetamine and Mdma Assay (2002), cited by 1
- K010226: Verdict -II Methamphetamine (2001), cited by 1
- K181305: OralTox Oral fluid Drug Test (2018), cited by 1

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