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Innovacon Spectrum II Test Card

by Innovacon, Inc.

510(k) K061718

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK061718 Date13 Nov 2006ClearedStatusActive

Recalls

6 recalls · FDA

    • Terminated Z-2881-2011 FDA Unclassified (pre-2012) initiated 10 Jun 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 order, these products were incorrectly labeled as CLIA Waived, when in fact the devices are classified as Moderately Complex. Therefore these devices are misbranded.

  • 5 recalls, same reason

    • Terminated Z-0008-2010 FDA Unclassified (pre-2012) initiated 27 Apr 2009
    • Terminated Z-0007-2010 FDA Unclassified (pre-2012) initiated 27 Apr 2009
    • Terminated Z-0009-2010 FDA Unclassified (pre-2012) initiated 27 Apr 2009
    • Terminated Z-0010-2010 FDA Unclassified (pre-2012) initiated 27 Apr 2009
    • Terminated Z-0006-2010 FDA Unclassified (pre-2012) initiated 27 Apr 2009

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DKZ
Device Class
Class II
Regulation
21 CFR Part 862.3100
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Innovacon Spectrum II Test Card is an enzyme immunoassay device designed for the qualitative and simultaneous detection of substances such as amphetamine, cocaine, marijuana, and benzodiazepines. It utilizes membrane-based test strips to provide results that assist in the diagnosis and treatment of drug use or overdose and in monitoring levels to ensure appropriate therapy.

This device is supplied as a test card or an integrated test cup and contains no electronic components or software. It is regulated under 21 CFR 862.3100 and has received FDA 510(k) clearance. Users should refer to the specific product documentation for storage requirements and handling instructions.

Other devices from Innovacon, Inc.

See all devices from Innovacon, Inc. →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Innovacon Spectrum II Test Card?

    This device is an enzyme immunoassay designed for the qualitative and simultaneous detection of substances including amphetamine, cocaine, marijuana, and benzodiazepines. It is used to assist in the diagnosis and treatment of drug use or overdose and to monitor levels to ensure appropriate therapy.

  • How is the Innovacon Spectrum II Test Card supplied?

    The device is supplied either as a test card or as an integrated test cup. It utilizes membrane-based test strips to provide results and contains no electronic components or software.

  • What is the regulatory status of this device?

    The Innovacon Spectrum II Test Card is regulated under 21 CFR 862.3100 and has received FDA 510(k) clearance.

  • How should the device be stored and handled?

    Users should refer to the specific product documentation provided with the device for all storage requirements and handling instructions to ensure the integrity of the test.