# K030211: Rapid Barbiturate Test Strip and Test Card, Models 7015 and 7016

- Pathway: 510(k) (Traditional)
- Applicant: Icn Biomedicals, Inc.
- Decided: Jun 13, 2003 after 143 days
- Product code: DKX (Thin Layer Chromatography, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Applied Biotech Surestep T'Drug Screen Test Barbiturate: named in the summary without a submission number

## Indications for use
Rapid Barbiturate Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result. Rapid Barbiturate Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GCMS, must be used in order to obtain a confirmed analytical result.

Source page: https://510kreport.com/device/K030211
Methodology: https://510kreport.com/methodology