INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)

K100051 · Alfa Scientific Designs, Inc. · DJG · Jul 6, 2010 · Clinical Toxicology

Device Facts

• Record ID: K100051
• Device Name: INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jul 6, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

The proposed drug of abuse device is intended for use in an OTC setting as an IVD screening test for any single one, or combination of, the following three substances in urine: Analyte Cutoff Morphine 300 ng/ml Oxycodone 100 ng/ml Oxycodone 300 ng/ml This test provides only a preliminary result. The results provided by this device indicate whether the drug or drug metabolite may be present. A positive result from the device is considered to be a presumptive result and should never be interpreted as final without laboratory confirmation.

Device Story

Lateral flow immunoassay; detects Morphine/Opiates and Oxycodone in urine; competitive binding principle. Device format: cup or cassette containing 1-3 test strips. Each strip features colloidal gold-labeled anti-drug antibodies and nitrocellulose membrane with test/control lines. User-operated (home use); sample applied to device; visual interpretation of colored bands. Presence of drug above cutoff inhibits test line development; control line confirms migration. Provides preliminary results; requires GC/MS or LC/MS confirmation. Benefits: rapid, accessible drug screening for lay users.

Clinical Evidence

Bench testing only; no clinical diagnostic data. OTC accuracy studies conducted at three sites with 264 total participants (136 for cup, 128 for cassette). Participants (ages 18-72) tested blind-labeled urine samples spiked with drugs at various concentrations relative to cutoffs. Results showed high agreement with GC/MS (97.16%-98.78% accuracy for cup; 97.7%-98.7% for cassette). Questionnaires confirmed ease of use and interpretation.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding. Components: colloidal gold-labeled anti-drug antibodies, nitrocellulose membrane with conjugated drug antigen. Format: cup or cassette. Built-in control line (C line). Temperature strip included in cup format. No electronic components or software.

Indications for Use

Indicated for home use by lay users for qualitative detection of Morphine/Opiates (300 ng/mL), Oxycodone (100 ng/mL), and Oxycodone (300 ng/mL) in human urine.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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).

Predicate Devices

• INSTANT-VIEW® Multi-Drugs Urine Test (K063545)
• INSTANT-VIEW® Oxycodone Urine Test (K063545)
• INSTANT-VIEW® Morphine (300) Urine Test (K060527)

Submission Summary (Full Text)

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Alfa Scientific Designs, Inc.

| 510(k) Summary | | | JUL-6 2010 |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------|
| Safety and effectiveness as required by 21 CFR 807.92 | | | |
| Manufacturer<br>and Submitter | Name: | Alfa Scientific Designs, Inc. | |
| | Address: | 13200 Gregg Street<br>Poway, CA 92064 | |
| | | Telephone: [phone] (direct)<br>Fax: [phone] | |
| | Contact Person: | Naishu Wang, MD, Ph.D.<br>Email: [e-mail] | |
| Device Name | Trade Name: | | |
| | INSTANT-VIEW® Drug of Abuse Urine (Cassette/Cup) Test<br>Drug of Abuse Urine (Cassette/Cup) Test | | |
| | Common Name: | | |
| | Immunoassay, Drug of Abuse Screen Urine Test | | |
| | | | |
| | Classification: | | |
| | Opiate Test System, Morphine Test System | | |
| | Product Code: | | |
| | DJG, NGI | | |
| | | | |
| Date of<br>Summary<br>Preparation | 06/30/2010 | | |
| Predicate<br>Devices | INSTANT-VIEW® Multi-Drugs Urine Test (510(k) Number: K063545)<br>INSTANT-VIEW® Oxycodone Urine Test (510(k) Number: K063545)<br>INSTANT-VIEW® Morphine (300) Urine Test (510(k) Number: K060527<br>Made by Alfa Scientific Designs, Inc. | | |
| Device<br>Description | A one-step lateral flow chromatographic immunoassay. The device<br>consists of any combination between one (1) to three (3) individual test<br>strip(s) for the drug(s) being tested. Each test strip in the device consists<br>of 1) a colored conjugate pad containing colloidal gold coupled with the<br>anti-drug antibodies and 2) nitrocellulose membrane containing a test<br>line (T line) coated with the conjugated drug antigen and a control line<br>(C line). The C line serves as an internal quality control of the system<br>and appears as a colored band during test regardless of the presence of<br>the drug. | | |
| Intended Use | The proposed drug of abuse device is intended for use in an OTC setting<br>as an IVD screening test for any single one, or combination of, the<br>following three substances in urine: | | |
| | Analyte | Cutoff | |
| | Morphine | 300 ng/ml | |
| | Oxycodone | 100 ng/ml | |
| | Oxycodone | 300 ng/ml | |
| | This test provides only a preliminary result. The results provided by<br>this device indicate whether the drug or drug metabolite may be present.<br>A positive result from the device is considered to be a presumptive<br>result and should never be interpreted as final without laboratory<br>confirmation. | | |
| Similarity to<br>the Predicate<br>Devices | • Both are one-step lateral-flow chromatographic immunoassays.<br>• Both are intended to provide qualitative detection of drug abuse.<br>• Both are in-vitro diagnostic devices.<br>• Both have a built-in quality control feature, C line, to indicate that an<br>adequate volume of specimen is applied and the liquid flow occurred<br>properly | | |
| Performance<br>Characteristics | The proposed drug of abuse device uses the same technology and<br>formulations for the detection of the drugs as individual test devices.<br>The performance characteristics, such as accuracy, reproducibility,<br>sensitivity and specificity of the multi-drug of abuse test are the same<br>as the individual tests, which have been 510(k) cleared for professional<br>use previously. | | |
| Stability | The shelf life stability of the test devices was done for each of the test<br>devices, three lots for each test in each format. The shelf life of the<br>proposed tests is two years (24 months) | | |
| Formats of the<br>Device | The proposed multi- drug of abuse device has two formats, cassette and<br>urine cup. | | |
| Conclusion | The proposed test is substantially equivalent to the predicate device. | | |

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## Multi-Drug of Abuse Urine Test

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the eagle.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Alfa Scientific Designs, Inc. C/O Naishu Wang 13200 Gregg St. Poway, CA 92064

JUL 0 0 0 2013

Re: k100051

Trade/Device Name: Instant-View Drug of Abuse Urine (Cassette/Cup) Test Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, NGI Dated: June 16, 2010 Received: June 17, 2010

Dear Ms. Wang:

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 class II (Special Controls), 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 requrements 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, 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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# Indications for Use Statement

## 510(k) number (if known): K100051

### Device Name:

INSTANT-VIEW® Drug of Abuse Urine (Cassette/Cup) Test

Drug of Abuse Urine (Cassette/Cup) Test

#### Indications for Use:

The Drug of Abuse Urine (Cassette/Cup) Test is a rapid qualitative immunoassay for the detection of potential abuse of one or more drugs: Morphine/Opiates, and Oxycodone (see list below). The device is intended for in vitro diagnostic home use.

| Abbreviation | Test | Calibrator | Cutoff |
|--------------|------------------|------------|-----------|
| MOR/OPI300 | Morphine/Opiates | Morphine | 300 ng/mL |
| OXY100 | Oxycodone | Oxycodone | 100 ng/mL |
| OXY300 | Oxycodone | Oxycodone | 300 ng/mL |

This assay provides only preliminary results. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

× Over-The-Counter Use AND/OR Prescription Use (Per 21 CFR 807 Subpart D) (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)

Dus

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K.100051 510/k)

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