INSTANT-VIEW MORPHINE URINE CASSETTE TEST

K994404 · Alfa Scientific Designs, Inc. · DPK · Jul 5, 2000 · Clinical Toxicology

Device Facts

• Record ID: K994404
• Device Name: INSTANT-VIEW MORPHINE URINE CASSETTE TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: DPK · Clinical Toxicology
• Decision Date: Jul 5, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3640
• Device Class: Class 2

Intended Use

The Instant-View Morphine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only. The US Substance Abuse and Mental Health Services Administration (SAMHSA) recommends the screening levels for Morphine to be at a concentration of 2000 ng/ml. This Test 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 Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.

Device Story

Instant-View Morphine Urine Cassette Test is a lateral flow chromatographic immunoassay for qualitative detection of morphine in human urine. Device utilizes competitive binding immunochemical sandwich assay principle; Morphine/Antibody/Morphine complexes form on test strip. Input is human urine sample; output is visual line pattern on cassette. Single C line indicates positive (morphine ≥ 300 ng/ml); two lines (C and T) indicate negative (morphine < 300 ng/ml). Used in clinical settings or physician offices by healthcare professionals. Provides preliminary screening results; requires confirmatory testing via GC/MS for clinical decision-making.

Clinical Evidence

Bench testing and clinical evaluation performed. Accuracy evaluation conducted at one clinical laboratory and three physician offices by personnel with diverse backgrounds; results showed 96.5% agreement with expected values. Correlation study against predicate device showed 91.6% agreement; inter-site agreement across three physician office locations was 92.5%.

Technological Characteristics

One-step lateral flow, competitive binding immunoassay. Utilizes immunochemical sandwich assay principle. Form factor is a urine cassette test. No electronic energy source or software components.

Indications for Use

Indicated for health care professionals to qualitatively detect morphine in human urine at a 300 ng/ml cutoff. Provides preliminary results; requires confirmation by alternate chemical methods like GC/MS.

Regulatory Classification

Identification

A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A morphine 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

• QuikStrip One Step Opiate Test (K972571)

Submission Summary (Full Text)

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## 510(K) Summary

In accordance with the Safe Medical Devices Act of 1990, a 510(K) summary is provided as outlined in 21 CFR 807.92.

| Submitter | Name: | Alfa Scientific Designs, Inc. |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | Address: | 11494 Sorrento Valley Road, Suite M<br>San Diego, CA 92121<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Name | Trade Name: Instant-View™ Morphine Urine Cassette Test | |
| | Common Name: Opiate Test | |
| | Classification Name: 21 CFR 862.3650, Class II | |
| Predicate Device | The Instant-View™ Morphine Urine Cassette Test is<br>substantially equivalent to other legally marketed devices<br>for the similar intended use. The device used for<br>comparison study is QuikStrip One Step Opiate Test,<br>manufactured by Syntron Bioresearch, Inc. with 510(K) #:<br>K972571, Date of Approval: 08/20/97. | |
| Device Description | This test is a one-step lateral flow chromatographic<br>immunoassay. | |
| Intended Use | The Instant-View™ Morphine Urine Cassette Test is a<br>qualitative immunoassay device intended to detect morphine<br>only in human urine at a cutoff level of 300 ng/ml. It is for<br>health care professional use only. | |
| Summary of the<br>Similarities to the<br>Predicate Device | • Intended Use:<br>Both devices are intended to detect morphine in human<br>urine at a cutoff level of 300 ng/ml.<br>• Interpretation of results:<br>The appearance of only a C line indicates a positive<br>result, and that the morphine level is at a cutoff level of<br>300 ng/ml or higher. And, the appearance of two lines –<br>both C line and T line indicates a negative result, and the | |

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| morphine level is below 300 ng/ml. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics:<br>• Both devices are one step, qualitative, competitive<br>binding immunoassay test, utilizing the basic<br>immunochemical sandwich assay principle of<br>recognition and formation of the specific Morphine/<br>Antibody/Morphine complexes. |
| Discussion and Conclusion |
| • The correlation of results from the Instant-View ™<br>Morphine Urine Cassette Test, and the legally<br>marketed test device compared, is higher than 91.6 %.<br>The results from all three POL sites agreed 92.5%. |
| • The Accuracy evaluation results from the Clinical<br>Laboratory and three Physician's Offices conducted by<br>persons with diverse educational background and<br>working experience agreed 96.5 % with the expected<br>results. |
| • Based on the results of the Performance Characteristics<br>and Comparison Studies, it may be concluded that the<br>Instant-View™ Morphine Urine Cassette Test is suitable<br>for use by health care professionals with diverse<br>educational backgrounds and work experiences, and is<br>substantially equivalent to the existing legally marketed<br>device. |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 5 2000

Ms. Rhoda Filipina QA Manager Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road Suite M San Diego, California 92121

Re: K994404

Trade Name: Instant-View Morphine Urine Cassette Test Regulatory Class: II Product Code: DPK Dated: June 6, 2000 Received: June 8, 2000

Dear Ms. Filipina:

We have reviewed your Section 510(k) notification of intent to market the device referenced wo have have 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 provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costilette Pro (110). - The general controls provisions of the Act include requirements for annual provisions of the read of thees, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( fecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mopelwaith the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow you to objin allating of your device to a legally marketed nonification. The I Dr I mailing of Sication for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire spoently an in vitro diagnostic devices), please contact the Office of Compliance at additionally 007.10 for millionally, for questions on the promotion and advertising of your device, [phone]. Tracklendly) (1) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K994404 510(k) Number (if known):

Instant-View Morphine Urine Cassette Test Device Name:

Indications For Use:

Instant-View Morphine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only.

The US Substance Abuse and Mental Health Services Administration (SAMHSA) recommends the screening levels for Morphine to be at a concentration of 2000 ng/ml.

This Test 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 Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Kim Cooper 1/3/00
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number *K 994404*