# DIS: Enzyme Immunoassay, Barbiturate

- Device class: 2; regulation: 21 CFR 862.3150; FDA's rule: 510(k) required
- FDA decisions: 100
- Recalls: 3 (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: 8
- 2002: 3
- 2003: 3
- 2004: 5
- 2005: 2
- 2007: 3
- 2011: 2
- 2014: 2
- 2015: 3
- 2016: 1

## Most-cited predicates
- K150791: Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) (2015), cited by 3
- K012824: Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test Device (2001), cited by 3
- K023946: Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug Multi-Line Screen Test Device (2003), cited by 2
- K041712: 'Rapidtec 4' Test (2004), cited by 2
- K042975: Ameditech Immutest Multi-Drug Screen Panel II (2004), cited by 2
- K070009: AT Home Drug Test Models, 9308T and 9308X (2007), cited by 2
- K032764: Barbiturate Enzyme Immunoassay, CA. # 0140 (500 Tests Kit); Cat# 0141 (5000 Tests Kit) (2003), cited by 1
- K000459: Urine Barbiturates (Barb) Screen Flex Reagent Cartridge, Catalog NO. DF 96A (2000), cited by 1
- K982551: Roche C0BAS Integra Serum Barbiturates Reagent Cassette, Abuscreeb Online Serum Barbiturates Calibrators, Roche Cobas in (1998), cited by 1
- K890690: Adx TM Barbiturates (1989), cited by 1

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