# K012996: Barbiturates

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 20, 2002 after 195 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902580 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902580: Emit (R) II Barbiturate Assay, Syva Co. (1990) Summary page 2.

## Indications for use
The Barbiturates assay is used for the qualitative analysis of barbiturates in human urine with a cutoff of 200 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatraent of barbiturates use or overdose. The Barbiturates assay is calibrated with secobarbital and will detcct a variety of Barbiturates. The Barbiturates assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical resull. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse Lest result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K012996
Methodology: https://510kreport.com/methodology