# LAF: Gas Chromatography, Methamphetamine

- Device class: 2; regulation: 21 CFR 862.3610; FDA's rule: 510(k) required
- FDA decisions: 49
- 510(k) review time 2021–2025: median 348 days (middle half 335–360)
- 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)
- 2006: 1
- 2008: 2
- 2011: 4
- 2012: 2
- 2014: 2
- 2015: 3
- 2016: 1
- 2017: 1
- 2020: 1
- 2021: 2

## Most-cited predicates
- K022589: Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test Device (2002), cited by 7
- K011672: Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test Device (2001), cited by 3
- K150096: Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) (2015), cited by 3
- K993208: STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I (2000), cited by 3
- K131652: Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls (2014), cited by 2
- K033299: Acon Mamp One Step Methamphetamine Test Strip and Test Device (2003), cited by 2
- K111927: Psychemedics Methamphetamine Eia (2012), cited by 1
- K062242: Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and Controls (2006), cited by 1
- K003845: Modification to Instant-View Methamphetamine (Meth 1000) Urine Test (Dip Strip) (2001), cited by 1
- K885071: Coat-a-Count Methamphetamin #TKMA1 (1989), cited by 1

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