# K012131: Livesure Benzodiazepines Screen Tests

- Pathway: 510(k) (Traditional)
- Applicant: Pan Probe Biotech, Inc.
- Decided: Jul 20, 2001 after 11 days
- Product code: JXM (Enzyme Immunoassay, Benzodiazepine)
- Device class: 2
- Regulation: 21 CFR 862.3170
- 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™ Benzodiazepines Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for detection of Benzodiazepines drugs, analogs and metabolites (BZD) 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 BZD/ml. The cut-off for both LiveSure™ Test Card and Test Strip device methods has been set at 300 ng BZD drug/ml based upon calibration using Oxazepam as a prototype Benzodiazepine/BZD drug, and using Oxazepam standards with a GC/MS method for the quantitation of all the Oxazepam 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™ BZD Screen Tests for BZD provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the 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/K012131
Methodology: https://510kreport.com/methodology