510(k) · Cleared
Recalled · 2011Innovacon Spectrum II Test Card
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovacon, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Nov 13, 2006 as substantially equivalent to K031759 (ACON Laboratories, Inc., 2003) and 6 other predicates after a 147-day review. Its family tree reaches back 4 generations to 1995. 80 later devices descend from it. It has been recalled 6 times.
- Decided
- Nov 13, 2006
- Review
- 147 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- 6
- Predicates
- 7
Its longest line of descent runs back 4 generations to K945610 (1995). 25 ancestors in all. 80 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 3 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 2 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 1 generation backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- This deviceK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006
- Descendant · cites it directly · 55 of its ownK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- Descendant · 2 generations on · 16 of its ownK140748 One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- Descendant · 2 generations on · 13 of its ownK182701 Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. · 2018 · Recalled
- Descendant · 2 generations on · 13 of its ownK142800 Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- Descendant · 2 generations on · 12 of its ownK181768 AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013 · cites it directly55descendants
- K140748One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2014 · 2 generations on16descendants
- K182701Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. · 2018 · 2 generations on13descendants
- K142800Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2014 · 2 generations on13descendants
- K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −3 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −2 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −1 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| 0 (this device) | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | — |
| +1 | 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 | — |
| +2 | K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2018 | 1 |
| +2 | K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2014 | — |
| +2 | K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 9 | 0 |
| 2016 | 9 | 0 |
| 2017 | 2 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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? (7)
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 |
|---|---|---|---|
| * | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug…Summary page 5…Number Code Number Code ACON Spectrum Multi-Drug Multi-Line Drug Screen Test K031759 LDJ DIO DKZ Card and Test Card with Integrated Split E-Z Key Cup DJG LCM JXM… | 2003 |
| * | K032903 | Acon Coc-150 One Step Cocaine Test Strip & Acon Coc-150 One Step Cocaine Test DeviceSummary page 5…Cup DJG LCM JXM DJR DIS LFG ACON COC-150 One Step Cocaine Test Strip/Test Device K032903 DIO ACON mAMP-500 One Step Methamphetamine Test K033299 LAF Strip/Test Device ACON PPX One Step Pr… | 2004 |
| * | K033299 | Acon Mamp One Step Methamphetamine Test Strip and Test DeviceSummary page 5…DJR DIS LFG ACON COC-150 One Step Cocaine Test Strip/Test Device K032903 DIO ACON mAMP-500 One Step Methamphetamine Test K033299 LAF Strip/Test Device ACON PPX One Step Propoxyphene Test Strip/Test Device K040445 JXN ACON AMP 300 One Step A… | 2003 |
| * | K040445 | Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test DeviceSummary page 5…903 DIO ACON mAMP-500 One Step Methamphetamine Test K033299 LAF Strip/Test Device ACON PPX One Step Propoxyphene Test Strip/Test Device K040445 JXN ACON AMP 300 One Step Amphetamine Test Strip/Test K041822 DKZ Device ACON OXY |I One Step Oxycodone Test S… | 2004 |
| * | K041822 | Acon Amp 300 One Step Amphetamine Test Strip and DeviceSummary page 5…033299 LAF Strip/Test Device ACON PPX One Step Propoxyphene Test Strip/Test Device K040445 JXN ACON AMP 300 One Step Amphetamine Test Strip/Test K041822 DKZ Device ACON OXY |I One Step Oxycodone Test Strip/Test Device K043507 DJG ACON BUP One Step Buprenorphine Test… | 2004 |
| * | K043507 | Acon Oxy II One Step Oxycodone Test Strip; Test DeviceSummary page 5…st Device K040445 JXN ACON AMP 300 One Step Amphetamine Test Strip/Test K041822 DKZ Device ACON OXY |I One Step Oxycodone Test Strip/Test Device K043507 DJG ACON BUP One Step Buprenorphine Test Strip/Test Device K060466 DJG… | 2005 |
| * | K060466 | Acon Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test…Summary page 5…Test K041822 DKZ Device ACON OXY |I One Step Oxycodone Test Strip/Test Device K043507 DJG ACON BUP One Step Buprenorphine Test Strip/Test Device K060466 DJG 5 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2006 |
What descends from it? (80)
See all 807 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | 2013 | 55 |
| K142396 | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests | 2014 | 10 |
| K111322 | Chemtrue Single/Multi-Panel Drug Screen Cassette/Dipcard | 2011 | 6 |
| K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen… | 2016 | 2 |
| K152590 | ACCU NEWS Drug Screening Test Card/Urine Cup | 2016 | 0 |
| K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 | 2015 | 0 |
| K130213 | Quickprofile Single Drug of Abuse Device and Quick Profile Multi-Drugs of Abuse Screen… | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2011 | Not classified | Z-2881-2011 | Vendor change control | Alere is initiating a voluntary recall on the listed lots of MULTI-DRUG 9 PANEL INTEGRATED CUP manufactured by Alere for sole use by Calloway Labs due to a mistake that occurred while processing the order, these products were incorrectly… |
| Apr 27, 2009 | Not classified | Z-0006-2010 | Process control | The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time. |
| Apr 27, 2009 | Not classified | Z-0007-2010 | Process control | The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time. |
| Apr 27, 2009 | Not classified | Z-0008-2010 | Process control | The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time. |
| Apr 27, 2009 | Not classified | Z-0009-2010 | Process control | The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time. |
| Apr 27, 2009 | Not classified | Z-0010-2010 | Process control | The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K122809 (Advin Biotech, 2013) has gone furthest, with 55 descendants of its own.
- 2 other devices also cite its predicate K031759.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Innovacon Spectrum II Test Card and Innovacon Spectrum II Test Card with Integrated Cups (Innovacon 014 Cup or E-Z Action Multi-Drug Test Cup and Innovacon 022 Cup or E-Z Start Multi-Drug Test Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methylenedioxymethamphetamine, Amphetamine, Morphine, Opiates, Methadone, Methamphetamine, Phencyclidine, Benzodiazepine, Oxycodone, Propoxyphene…
Read the full statement (256 words)
The Innovacon Spectrum II Test Card and Innovacon Spectrum II Test Card with Integrated Cups (Innovacon 014 Cup or E-Z Action Multi-Drug Test Cup and Innovacon 022 Cup or E-Z Start Multi-Drug Test Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methylenedioxymethamphetamine, Amphetamine, Morphine, Opiates, Methadone, Methamphetamine, Phencyclidine, Benzodiazepine, Oxycodone, Propoxyphene, Tricyclic Antidepressants, Buprenorphine and Barbiturate in human urine at the cutoff concentrations of:
1,000 ng/mL or 300 ng/mL for Amphetamine,
300 ng/mL for Barbiturate,
300 ng/mL for Benzodiazepines,
300 ng/mL or 150 ng/mL for Cocaine,
50 ng/mL for Marijuana,
300 ng/mL for Methadone,
500 ng/mL or 1,000 ng/mL for Methamphetamine,
500 ng/mL for Methylenedioxymethamphetamine,
300 ng/mL for Morphine,
2,000 ng/mL for Opiates,
100 ng/mL for Oxycodone,
25 ng/mL for Phencyclidine,
300 ng/mL for Propoxyphene,
10 ng/mL for Buprenorphine, and
1,000 ng/mL for Tricyclic Antidepressants.
Configurations of the Innovacon Spectrum II Test Card and Innovacon Spectrum II Test Card with Integrated Cups (Innovacon 014 Cup or E-Z Action Multi-Drug Test Cup and Innovacon 022 Cup or E-Z Start Multi-Drug Test Cup) can consist of any combination of the above listed drug analytes. They are intended for healthcare professionals including professionals at point-of-care sites.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061718 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061718: Innovacon Spectrum II Test Card.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061718
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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