510(k) · Cleared
ClearedAtlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlas Medical · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Oct 3, 2019 as substantially equivalent to K153050 (Co-Innovation Biotech Co., Ltd., 2016) after a 161-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Oct 3, 2019
- Review
- 161 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945610 (1995). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 7 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 6 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 5 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 4 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 3 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 2 generations backK140748 One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- 1 generation backK153050 Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2016
- This deviceK191099 Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening…Atlas Medical · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −7 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −6 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −5 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −4 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −3 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −2 | K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2014 | — |
| −1 | K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2016 | — |
| 0 (this device) | K191099 | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel | Atlas Medical | 2019 | — |
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 |
| 2014 | 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 |
|---|---|---|---|
| * | K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardSummary page 6…rugs Screening Tests (Cup and Panel Formats) has been determined to be substantially equivalent (Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard) (K 153050) currently in commercial distribution and manufactured by Co-innovation Biotech Co., ltd. (K153050). 4- Device description: 1)… | 2016 |
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 24 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 30 ancestors have a recall of any class.
- 4 other devices also cite its predicate K153050.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Atlas Multi-Drugs Screening Test Cup and Atlas Multi-Drugs Screening Test Panel are lateral flow chromatographic in vitro diagnostics immunoassays for the qualitative detection of following drugs in urine without the need of instruments: Drug Name Calibrator Cut-off Amphetamine (AMP) D-Amphetamine 1000 Methylenedioxymethamphetamine (MDMA) D,L Methylenedioxymethamphetamine 500 Morphine (MOP) Morphine 300 Morphine (MOP) Morphine 2000 Oxycodone (OXY)…
Read the full statement (221 words)
Atlas Multi-Drugs Screening Test Cup and Atlas Multi-Drugs Screening Test Panel are lateral flow chromatographic in vitro diagnostics immunoassays for the qualitative detection of following drugs in urine without the need of instruments:
Drug Name Calibrator Cut-off
Amphetamine (AMP) D-Amphetamine 1000
Methylenedioxymethamphetamine (MDMA) D,L Methylenedioxymethamphetamine 500
Morphine (MOP) Morphine 300
Morphine (MOP) Morphine 2000
Oxycodone (OXY) Oxycodone 100
Cocaine (COC) Benzoylecgonine 300
Nortriptyline Nortriptyline 1000
Methamphetamine (MET) D-Methamphetamine 1000
Phencyclidine (PCP) Phencyclidine 25
Marijuana (THC) 11-nor-Δ⁹-THC-9 COOH 50
Secobarbital Secobarbital 300
Oxazepam Oxazepam 300
Methadone (MTD) Methadone 300
Propoxyphene (PPX) Propoxyphene 300
Buprenorphine(BUP) Buprenorphine 10
The tests are intended for professional use only. The tests will yield preliminary positive results when the prescription drugs Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline in urine. The multi-drugs screening tests (Cup and Panel formats) show the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191099: Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191099
Report an extraction error
Are you the manufacturer?
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