INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST

K994398 · Alfa Scientific Designs, Inc. · DIO · Jul 27, 2000 · Clinical Toxicology

Device Facts

• Record ID: K994398
• Device Name: INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Jul 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

The Instant-View™ Cocaine (Benzoylecgonine) Urine Cassette Test is a qualitative immunoassay device intended to detect Benzoylecgonine in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only. 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

One-step lateral flow chromatographic immunoassay; detects benzoylecgonine in human urine. Principle: competitive binding immunoassay using specific benzoylecgonine/antibody complexes. Input: human urine sample. Output: visual interpretation of lines on cassette (one line = positive, two lines = negative). Used in clinical settings or physician office laboratories (POL) by healthcare professionals. Provides preliminary screening results; requires GC/MS confirmation for clinical decision-making. Benefits: rapid, qualitative assessment of cocaine metabolite presence.

Clinical Evidence

Bench testing and clinical performance studies conducted. Accuracy evaluation performed at a clinical laboratory and three Physician's Office Laboratory (POL) sites by diverse personnel. Results showed 97.8% agreement with expected results. Correlation with predicate device was >92.9%. POL site agreement was 93.3%. Study utilized GC/MS as the reference method for confirmation.

Technological Characteristics

Lateral flow chromatographic immunoassay; competitive binding format. Utilizes immunochemical sandwich assay principle. Form factor: urine cassette. Qualitative visual readout. No electronic components, software, or external energy source required.

Indications for Use

Indicated for healthcare professionals to qualitatively detect benzoylecgonine (cocaine metabolite) in human urine at a 300 ng/ml cutoff. Provides preliminary results requiring GC/MS confirmation.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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 Cocaine Test (K971926)

Submission Summary (Full Text)

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K994398

## Alfa Scientific Designs, Inc.

11494 Sorrento Valley Road, S San Diego, CA 92121

## 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™ Cocaine (Benzoylecgonine)<br>Urine Cassette Test | |
| | Common Name: Cocaine Test | |
| | Classification Name: 21 CFR 862.3250, Class II | |
| Predicate Device | The Instant-View™ Cocaine (Benzoylecgonine) Urine Cassette Test is substantially equivalent to other legally<br>marketed devices for the similar intended use. The device<br>used for comparison study is QuikStrip One Step Cocaine<br>Test, manufactured by Syntron Bioresearch, Inc. with<br>510(K) #: K971926, Date of Approval: 07/14/97. | |
| Device Description | | This test is a one-step lateral flow chromatographic<br>immunoassay. |
| Intended Use | | The Instant-View™ Cocaine (Benzoylecgonine) Urine<br>Cassette Test is a qualitative immunoassay device intended<br>to detect Benzoylecgonine in human urine at a cutoff level<br>of 300 ng/ml. It is intended for health care professional use<br>only. |
| Summary of the<br>Similarities to the<br>Predicate Device | • Intended Use: | Both devices are intended to detect Benzoylecgonine in<br>human urine at a cutoff level of 300 ng/ml.<br>• Interpretation of results:<br>The appearance of only one - C line, indicates a positive<br>result, and that the Benzoylecgonine level is at a cutoff<br>level of 300 ng/ml or higher. And, the appearance of two |
| | lines – both C line and T line indicates a negative result,<br>and that the Benzoylecgonine level is below 300 ng/ml.<br>• 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<br>Benzoylecgonine/Antibody/Benzoylecgonine complexes. | |
| Discussion and<br>Conclusion | • The correlation of results from the Instant-View™<br>Cocaine (Benzoylecgonine) Urine Cassette Test, and the<br>legally marketed test device compared, is higher than<br>92.9 %. The results from the three POL sites agreed<br>93.3 %. | |
| | • The Accuracy Evaluation results from the Clinical<br>Laboratory and the three Physician's Offices Laboratory<br>conducted by persons with diverse educational<br>backgrounds and working experience agreed 97.8 % with<br>the results expected. | |
| | • Based on the results of the Performance Characteristics<br>and Comparison Studies, it may be concluded that the<br>Instant-View™ Cocaine (Benzoylecgonine) Urine<br>Cassette Test is suitable for use by health care<br>professionals with diverse educational backgrounds and<br>work experiences, and it is substantially equivalent to the<br>existing legally marketed device. | |

510(K) Summary: K994398 Instant-View™ Cocaine (Benzoylecgonine) Urine Cassette Test

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## Additional Information:

- Package Insert of the Predicate Device. A:
- Records of Raw Data from the In-House Sensitivity Study B:
- Raw Data for Precision Study from the three different POL sites. C:
- Raw Data for Accuracy Study from the three POL sites and the Reference D: Laboratory.
- Tabulated Results (Ascending Concentration) of the Accuracy Study form the E: Tabulaton (results (risemans ) Laboratory with the GC/MS Data the Toxicology Laboratory.

Source of Clinical Samples: Unilab Corporation

Toxicology Laboratory 18408 Oxnard Street Tarzana, CA 91356 Tel: [phone] Fax: [phone] Contact Person: Ali Mikhchi

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping, abstract shapes that resemble a bird in flight or flowing ribbons.

## JUL 2 7 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K994398 Re:

Trade Name: Instant-View Cocaine (Benzoylecgonine) Urine Cassette Test Regulatory Class: II Product Code: DIO Dated: June 30, 2000 Received: July 6, 2000

Dear Ms. Filipina:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting 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 comply with 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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at [phone]. 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Dutman

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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K994398 510(k) Number (if known):

Device Name: Instant-View Cocaine (Benzoylecgonine) Urine Cassette Test
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Indications For Use:

Instant-View Cocaine (Benzoylecgonine) Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect benzoylecgonine, a metabolite of cocaine in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only.

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) | |
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OR

| Over-The-Counter-Use (Optional Format 1-2-96) | |
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| (Division Sign-Off) | |
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| Division of Clinical Laboratory Devices | |
| 510(k) Number | K994398 |