510(k) · Cleared
ClearedACCU NEWS Drug Screening Test Card/Urine Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coretests, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Apr 15, 2016 as substantially equivalent to K061718 (Innovacon, Inc., 2006) after a 218-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Apr 15, 2016
- Review
- 218 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945610 (1995). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 4 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 3 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 2 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 1 generation backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- This deviceK152590 ACCU NEWS Drug Screening Test Card/Urine CupCoretests, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −4 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −3 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −2 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −1 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| 0 (this device) | K152590 | ACCU NEWS Drug Screening Test Card/Urine Cup | Coretests, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061718 | Innovacon Spectrum II Test CardSummary page 4…Test System Marijuana LDJ 21 CFR 862.3870, Cannabinoids Test System C. Predicate Device K061718 Innovacon® Spectrum II Test Card/Test Card with Integrated Cups D. Device Description ACCU NEWS® Drug Screening Test Card/Ur… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 26 ancestors have a recall of any class.
- 6 other devices also cite its predicate K061718.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (144 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152590: ACCU NEWS Drug Screening Test Card/Urine Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152590
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026