# K152590: ACCU NEWS Drug Screening Test Card/Urine Cup

- Pathway: 510(k) (Traditional)
- Applicant: Coretests, Inc.
- Decided: Apr 15, 2016 after 218 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- 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 4.

## Indications for use
The ACCU NEW® Drug Screening Test Card/Urine Cup are immunochromatographic assays for the qualitative determination of the drugs/drug metabolites in human urine. The test cutoff concentrations and the compounds the tests are calibrated to are as follows: Analyte Abbreviation Calibrator Cutoff (ng/ml) Amphetamine AMP d-Amphetamine 1000 Methamphetamine MET d-Methamphetamine 1000 Morphine MOP Morphine 300 Cocaine CcocC Benzoylecgonine 300 Marijuana THC 11-Nor-9-THC-9-COOH 50 The ACCU NEWS® Drug Screening Test Card /Urine Cup can consist of any combination of the drug analytes listed above. For m vitro diagnostic use only. The tests are intended for both prescription and over-the-counter (OTC) use. The device provides only a preliminary result. A more specific alternative chemical method must be used i order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass be exercised for any drugs of abuse test results, particularly when preliminary results are positive.

Source page: https://510kreport.com/device/K152590
Methodology: https://510kreport.com/methodology