# K012133: Livesure Barbiturates Screen Test

- Pathway: 510(k) (Traditional)
- Applicant: Pan Probe Biotech, Inc.
- Decided: Jul 20, 2001 after 11 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
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) EMIT® II Assay: named in the summary without a submission number

## Indications for use
The Pan Probe Biotech LiveSure™ Barbiturates Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for detection of Barbiturate drugs (e.g., Secobarbital, Pentabarbital, Phenobarbital, etc.), analogs and metabolites (collectively termed: BAR) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 300 ng BAR/ml. The cut-off for both LiveSure™ Test Card and Test Strip device methods has been set at 300 ng BAR drug/ml based upon calibration using Secobarbital as a prototype Barbiturate/BAR drug, and using Secobarbital standards with a GC/MS method for the quantitation of all the Secobarbital standard and urine test solutions. These IVD Tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. Pan Probe Biotech LiveSure™ BAR Screen Tests for BAR provide only preliminary analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. Both NIDA and SAMHSA have established gas chromatography/mass spectrometry (GC/MS) as a preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Source page: https://510kreport.com/device/K012133
Methodology: https://510kreport.com/methodology