# K061718: Innovacon Spectrum II Test Card

- Pathway: 510(k) (Special)
- Applicant: Innovacon, Inc.
- Decided: Nov 13, 2006 after 147 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945610 (1995). 25 ancestors in all.
80 later devices descend from it; 7 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031759: Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card, ACON Laboratories, Inc. (2003) Summary page 5.
- K032903: Acon Coc-150 One Step Cocaine Test Strip & Acon Coc-150 One Step Cocaine Test Device, ACON Laboratories, Inc. (2004) Summary page 5.
- K033299: Acon Mamp One Step Methamphetamine Test Strip and Test Device, ACON Laboratories, Inc. (2003) Summary page 5.
- K040445: Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test Device, ACON Laboratories, Inc. (2004) Summary page 5.
- K041822: Acon Amp 300 One Step Amphetamine Test Strip and Device, ACON Laboratories, Inc. (2004) Summary page 5.
- K043507: Acon Oxy II One Step Oxycodone Test Strip; Test Device, ACON Laboratories, Inc. (2005) Summary page 5.
- K060466: Acon Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test Device, ACON Laboratories, Inc. (2006) Summary page 5.

## Most influential descendants
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (2013), 55 descendants of its own
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard (2014), 16 descendants of its own
- K182701: Wondfo T-Cup Multi-Drug Urine Test Cup (2018), 13 descendants of its own
- K142800: Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard (2014), 13 descendants of its own
- K181768: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (2018), 12 descendants of its own

## Recalls of this device
- Jun 10, 2011 · Not classified · Z-2881-2011: 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 o
- Apr 27, 2009 · Not classified · Z-0006-2010: 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 t
- Apr 27, 2009 · Not classified · Z-0007-2010: 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 t
- Apr 27, 2009 · Not classified · Z-0008-2010: 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 t
- Apr 27, 2009 · Not classified · Z-0009-2010: 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 t
- Apr 27, 2009 · Not classified · Z-0010-2010: 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 t

## Indications for use
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.

Source page: https://510kreport.com/device/K061718
Methodology: https://510kreport.com/methodology