# K043211: Online Dat Barbiturates Plus

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 29, 2004 after 40 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: 2 generations back to K914468 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983698: Modification to Abuscreen Online Barbiturates, Roche Diagnostic Systems, Inc. (1999) Summary page 1.

## Indications for use
Barbiturates Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose. Barbiturates Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

Source page: https://510kreport.com/device/K043211
Methodology: https://510kreport.com/methodology