(147 days)
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, Methamphetamine, Phencyclidine, Morphine, Opiates, Methadone, Amphetamine, 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.
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 competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methylenedioxymethamphetamine, Methamphetamine, Phencyclidine, Morphine, Opiates, Methadone, Amphetamine, 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.
These tests can be performed without the use of an instrument.
A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing of Marijuana, Cocaine, Methylenedioxymethamphetamine, Amphetamine, Opiates, Methadone, Methamphetamine, Phencyclidine, Benzodiazepine, Propoxyphene, Tricyclic Antidepressants, Buprenorphine and Barbiturate at the concentrations below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a color line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
The provided text describes a 510(k) submission for a multi-drug screening device. While it details the device's intended use and classification, it does not include specific acceptance criteria, comprehensive performance study results (beyond stating it's "similar to other FDA-cleared devices"), or information about training data, ground truth establishment, or expert involvement in evaluation.
Therefore, many of the requested points cannot be extracted from the given input.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not provided in the document. The document states the device is "similar to other FDA-cleared devices for the qualitative and simultaneous detection..." implying that its performance aligns with those predicate devices, but no explicit acceptance criteria or detailed performance metrics are listed for the Innovacon Spectrum II Test Card itself.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a rapid immunoassay for qualitative detection of substances in urine, not an AI-assisted diagnostic imaging device that uses human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a "standalone" test in the sense that it's a lateral flow immunoassay performed without an instrument, directly producing a visual result. However, it's not an algorithm, so the phrasing "algorithm only" doesn't quite fit. The document specifies, "These tests can be performed without the use of an instrument." The results are interpreted visually by a healthcare professional at point-of-care.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document states, "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." This indicates that GC/MS would be the primary method for establishing ground truth/confirmation.
8. The sample size for the training set
Not provided in the document.
9. How the ground truth for the training set was established
Not provided in the document, but it's reasonable to infer that if a training set were used (which is typical for device development, though not explicitly mentioned here), the ground truth for it would also rely on confirmatory methods like GC/MS, consistent with item #7.
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510(k) SUMMARY
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Assigned 510(k) number is ________________________________________________________________________________________________________________________________________________
Submitter:
INNOVACON Laboratories, Inc. 4106 Sorrento Valley Boulevard San Diego, California 92121
Tel.: 858-535-2030 Fax: 858-535-2038
Date:
June 16, 2006
Contact Person:
Edward Tung, Ph.D.
Product Names:
Innovacon® Spectrum II Test Card 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)
Common Name:
Multi-drug Multi-line lateral flow immunochromatographic test for the simultaneous and Miniti drug Mani Inte Amonetamine, Cocaine, Marijuana, Benzodiazepines, Tricyclic Antidepressants, Barbiturates, Morphine, Phencyclidine, Oxycodone, Propoxyphene, Methadone, Opiate, Methamphetamine, Buprenorphine and Methylenedioxymethamphetamine in urine.
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Regulation Name:
Amphetamine, Cocaine, Marijuana, Benzodiazepines, Tricyclic Antidepressants, Barbituretes, Methadone, Opiate, Propoxyphene, Oxycodone, Phencyclidine, and Morphine, Methylenedioxymethamphetamine, Buprenorphine and Methamphetamine test systems.
Product Code:
LDJ, DIO, DJC, DKZ, DJG, LCM, JXM, DJR, DIS, LFG, LAF, JXN
Classification Number:
21 CFR § 862.3870, 21 CFR § 862.3250, 21 CFR § 862.3610, 21 CFR § 862.3100, 21 CFR § 862.3650, 21 CFR § 862.3170, 21 CFR § 862.3620, 21 CFR § 862.3150, 21 CFR § 862.3910, 21 CFR § 862.3700
Device Classification:
Cocaine, Marijuana, Benzodiazepines, Tricyclic Antidepressants, Amphetamine, The The Timplecalinne, Cophen, vclidine, Oxycodone, Propoxyphene, Methadone, Opiate, Buttylenedioxymethamphetamine, Buprenorphine and Methamphetamine test systems have been classified as Class II devices with moderate complexity.
The Innovacon Spectrum II Test Card and Innovacon Spectrum II Test Card with Integrated The Innovacon 014 Cup or E-Z Action Multi-Drug Test Cup and Innovacon 022 Cup or E-Z Start Multi-Drug Test Cup) are similar to other FDA-cleared devices for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Benzodiazepines, Tricyclic Barbiturates, Morphine, Phencyclidine, Oxycodone, Propoxyphene, Antidepressants, Methadone, Opiate, Methylenedioxymethamphetamine, Buprenorphine and Methamphetamine in human urine.
Intended 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 of Marijuana, Cocaine, Methylenedioxymethamphetamine, Methamphetamine, Phencyclidine, Morphine, Opiates, Methadone, Amphetamine、
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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 Configurations of the minorators Spowacon 014 Cup or E-Z Action Multi-Drug Test Cup Card with with megrated Cup 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 I his assay provides only a premiment to obtain a confirmed analytical result. Gas chemical method mast be used in order to oare 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.
Description:
The Innovacon Spectrum II Test Card and Innovacon Spectrum II Test Card with with 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 competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous detection of Marijuana, minunoon ontaograpino weethamphetamine, Amphetamine, Morphine, Opiates, Methadone, Coounte, Hearine, Phencyclidine, Benzodiazepine, Propoxyphene, Tricyclic Methamphonines, "I nonerphine and Barbiturate in human urine at the cutoff concentrations of:
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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.
These tests can be performed without the use of an instrument.
A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing of Marijuana, Cocaine, Methylenedioxymethamphetamine, Amphetamine, Opiates, Methadone, Methamphetamine, Phencyclidine, Benzodiazepine, Propoxyphene, Tricyclic Antidepressants, Buprenorphine and Barbiturate at the concentrations below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a color line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Unmodified ACON Devices:
The Innovacon® Spectrum II Test Card and Innovacon Spectrum II Test Card with 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 a "modified" product format derived from the previously FDA-cleared ACON Spectrum Multi-drug Multi-line Drug Screen Test Card and 6 ACON Single DOA Tests. These seven legally marketed but unmodified devices and their 510(k) numbers under which thev were previously cleared are listed in Table 1.
· i
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| Previously Cleared ACON Drug of Abuse Test | 510(k)Number | ProductCode |
|---|---|---|
| ACON Spectrum Multi-Drug Multi-Line Drug Screen TestCard and Test Card with Integrated Split E-Z Key Cup | K031759 | LDJ DIO DKZDJG LCM JXMDJR DIS LFG |
| ACON COC-150 One Step Cocaine Test Strip/Test Device | K032903 | DIO |
| ACON mAMP-500 One Step Methamphetamine TestStrip/Test Device | K033299 | LAF |
| ACON PPX One Step Propoxyphene Test Strip/Test Device | K040445 | JXN |
| ACON AMP 300 One Step Amphetamine Test Strip/TestDevice | K041822 | DKZ |
| ACON OXY II One Step Oxycodone Test Strip/Test Device | K043507 | DJG |
| ACON BUP One Step Buprenorphine Test Strip/Test Device | K060466 | DJG |
Table 1. Unmodified ACON Devices with K Numbers and Product Codes.
·
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is facing to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 3 2006
Edward Tung, Ph.D. INNOVACON Laboratories, Inc. 4106 Sorrento Valley Boulevard San Diego, California 92121
Re: K061718 Trade/Device Name: Innovacon Spectrum II Test Card 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) Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM, JXN Dated: October 20, 2006 Received: October 23, 2006
Dear Dr. Tung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I his icher will anow you to oogin manies.ing of substantial equivalence of your device to a legally premarks notification: "The PDF interestion for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements o your device, If you destions on the promotion and advertising of your device, please contact the Office of In of quostions on the promotion and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou ittay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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10. INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Innovacon Spectrum II Test Card Innovacon Spectrum II Test Card with Integrated Cups (Innovacon 014 Cup of mnovacon Spectran II - Fost Sard Innovacon 022 Cup or E-Z Start Multi-Drug Test Cup)
Indications for Use:
The Innovacon Spectrum II Test Card and Innovacon Spectrum III Test Card with Integrated The Innovacon Spectrum in Test Gard and Innovacon 022 Cup and Innovacon 022 Cup or E-Z Cups (Innovacon 014 Cup of L-Z Actor Man Graghic immunoassay for the qualitative and Methylenedioxymethamphetamine, detection of Marijuana, Cocaine, simultaneous Morphine, Opiates, Opiates, Methadone, Methamphetamine, Phencyclidine, Amphetamine, Amprelamine, - Morphine, - Oplates, - Mothadone, - Mothauone, - Morenorphine 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 na/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 Oomigurations of the Innovacon Opecial of E-Z Action Multi-Drug Test Cup and Innovacon 022 with miegated Cups (Innovation of any combination of the above listed drug Oup of E-Z Otalt Mall Drug Toot Sap) Star Support of Sectionals 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 method must be accurrometry (GC/MS) are the preferred confirmatory methods. Clinical chromatographymaco open on (next should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Prescription Use ... X ... (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Bumen
AND/OR
sion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).