# K130213: Quickprofile Single Drug of Abuse Device and Quick Profile Multi-Drugs of Abuse Screen Device

- Pathway: 510(k) (Traditional)
- Applicant: Lumiquick Diagnostics, Inc.
- Decided: Oct 18, 2013 after 262 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945610 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061718: Innovacon Spectrum II Test Card, Innovacon, Inc. (2006) Summary page 2.

## Indications for use
LumiQuick's QuickProfile Single Drugs of Abuse and QuickProfile Multi-Drugs of Abuse Screen Devices are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to nine of the following drugs in a variety of combinations in human urine. Both devices are available in test strip, dip panel, cassette panel and cup formats. The designed cutoff concentrations and direct calibrator for these drugs are as follows: AMP Amphetamine 1000 ng/ml BAR Secobarbital 300 ng/ml BZO Oxazepam 300 ng/ml COC Benzoylecgonine 300 ng/ml MTD Methadone 300 ng/ml MAMP Methamphetamine 1000 ng/ml OPI Morphine 300 ng/ml PCP Phencyclidine 25 ng/ml THC THC I 1-nor-A9-THC-9-COOH 50 ng/ml These devices are intended for prescription use only. These assays provide only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method. Clinical consideration 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/K130213
Methodology: https://510kreport.com/methodology