VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE

K993485 · Sun Biomedical Laboratories, Inc. · DIO · Dec 27, 1999 · Clinical Toxicology

Device Facts

• Record ID: K993485
• Device Name: VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE
• Applicant: Sun Biomedical Laboratories, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Dec 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Indications for Use

Simultaneous qualitative visual tests for five (5) drugs of abuse: Cocaine, Morphine, Cannabinoids, Methamphetamine and Phencyclidine and their metabolites in urine sample.

Device Story

Visualine V Drugs of Abuse Dipstrip Panel is an in-vitro diagnostic test for qualitative detection of five drugs of abuse in human urine. Device utilizes competitive immunochromatographic technique; urine sample wicks through porous membrane; drug in sample competes with drug-labeled microspheres for limited antibody binding sites. Presence of drug inhibits formation of colored precipitin at probe site. Test performed by dipping panel into urine sample; results interpreted via visual color comparison after 5 minutes. Used in clinical or laboratory settings for rapid screening. Provides qualitative results to healthcare providers to assist in identifying potential drug use; requires confirmation by alternative chemical methods for definitive identification.

Clinical Evidence

Clinical correlation studies conducted at Redwood Toxicology Laboratory and Sun Biomedical Laboratories. Compared Visualine V Dipstrip Panel against Hitachi 717 EIA analyzer using blinded urine samples. Results: Cocaine (Sensitivity 98%, Specificity >99%, Efficiency >99%); Cannabinoids, Morphine, Methamphetamine, and Phencyclidine (Sensitivity >99%, Specificity >99%, Efficiency >99%). Reproducibility studies (within-run, run-to-run, day-to-day, lot-to-lot) all >99%.

Technological Characteristics

Competitive immunochromatographic assay; utilizes polyclonal and monoclonal antibodies; tracer is Ab colloidal complex; porous membrane test strip; visual color precipitin detection; storage 2-30°C; no ancillary equipment required.

Indications for Use

Indicated for the qualitative detection of Cocaine, Morphine, Cannabinoids, Methamphetamine, and Phencyclidine and their metabolites in human urine samples.

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).

Reference Devices

• Hitachi 717 instrument (using Diagnostic Reagents, Inc. EIA)

Submission Summary (Full Text)

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DEC 27 1999

K993485

SUN BIOMEDICAL LABORATORIES, INC.

604 VPR CENTER, 1001 LOWER LANDING ROAD, BLACKWOOD, NJ 0801 TEL: [phone] • FAX: [phone] • E-mail: sunlabs@juscom.c

## 510(k) CONTENT SUMMARY

1. Name of Manufacturer:

Sun Biomedical Laboratories, Inc. 604 VPR Center 1001 Lower Landing Road Blackwood, NJ 08012

- 2. Trade Name Visualine®V Drugs of Abuse Dipstrip Panel for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine and their metabolites in Human Urine Samples.
- 3. Common Name

An in-virro immunoassay test by visual color comparison for the detection of Cocaine. Carnabinoids, Morphine, Methamphetamine, and Phencvclidine in human urine samples,

### 4. Regulation # and Classification:

Reg. #862-3170, Class II Device

- 5. Test Description:
The Visualine® V Drugs of Abuse Dipstrip Panel test is based on the principle of antigen-antibody complexation and is used for the analysis of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine and their corresponding metabolites in human urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered through a wicking action as the panel (holding the porous membrane) is dipped into the urine sample. The drug in the sample compeics for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site.

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# 6. Comparison of Two Test Systems for Correlation Studies:

The Visualine@V Drugs of Abuse Dipstrip Panel for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine assay is correlated to the individual Hitachi 717 instrument using Diagnostic Reagents, Inc. material. The following table illustrates the similarities and differences between the two assays.

| | Hitachi 717<br>(Diagnostic Reagents, Inc EIA) | Visualine®V Drugs of Abuse<br>Dipstrip Panel for Qualitative<br>Determination of Cocaine,<br>Cannabinoids, Morphine,<br>Methamphetamine, and<br>Phencyclidine |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Principle | Homogenous enzyme<br>immunoassay | Competitive binding<br>immunoassay |
| Sample/Sample Size | 200 uL urine | Approx. 200 ul urine |
| Antibody | Polyclonal and Monoclonal | Polyclonal and Monoclonal |
| Tracer | Drug-Glucose-6-Phosphate<br>Dehydrogenase | Ab Colloidal Complex |
| Detection Method | Change in absorbance (ΔΑ) value<br>detected spectrophotometrically | Visual color<br>precipitin formation |
| Test Run Time | 10-20 minutes, dependent on test | 5 minutes |
| Storage Requirement | 2-8°C (36-46°F) | 2-30°C (36-86°F) |
| Detection Level | Cocaine<br>300 ng/ml<br>Cannabinoids<br>50 ng/ml<br>Morphine<br>300 ng/ml<br>Methamphetamine<br>1000 ng/ml<br>Phencyclidine<br>25 ng/ml | 300 ng/ml<br>50 ng/ml<br>300 ng/ml<br>1000 ng/ml<br>25 ng/ml |
| Ancillary Equipment | 717 Hitachi Analyzer, EIA<br>Calibrators | none |

# 7. Visualine®V Dipstrip Panel Performance Characteristics

- A. Correlation studies between Diagnostic Reagents, Inc. EIA individual assays and Visualine® V dipstrip Panel for Cocaine and it's metabolites, Cannabinoids and it's metabolites, Morphine and it's metabolites, Methamphetamine, and Phencyclidine were conducted at Redwood Toxicology Laboratory, Santa Rosa California and Sun Biomedical Laboratories. Presumptive positive samples (tested on the Hitachi) for each drug were provided by Redwood and tested at Sun Biomedical Labs where blinded studies were conducted to determine the correlation between the two methodologies. Negative samples consisted of UTAK Laboratories Drug Free Urine

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pool, Lot# 2647, and in-house negative urines tested with Sun Biomedical's Visualine® II product. Correlation with Hitachi 717 yielded the following data:

| Cocaine: | Sensitivity | 49 / 50 | 98 % |
|------------------|-------------|-----------|-------|
| | Specificity | 247 / 247 | >99 % |
| | Efficiency | 296 / 297 | >99 % |
| Cannabinoids: | Sensitivity | 50 / 50 | >99 % |
| | Specificity | 253 / 253 | >99 % |
| | Efficiency | 303 / 303 | >99 % |
| Morphine: | Sensitivity | 50 / 50 | >99 % |
| | Specificity | 257 / 257 | >99 % |
| | Efficiency | 307 / 307 | >99 % |
| Methamphetamine: | Sensitivity | 50 / 50 | >99 % |
| | Specificity | 255 / 255 | >99 % |
| | Efficiency | 305 / 305 | >99 % |
| Phencyclidine: | Sensitivity | 50 / 50 | >99 % |
| | Specificity | 255 / 255 | >99 % |
| | Efficiency | 305 / 305 | >99 % |

#### B. Specificity and Substances Detected:

The individual tests are specific to the labeled drug of abuse or structurally related The test detects Cocaine and its metabolites at 300 ng/ml, compounds. Cannabinoids and its metabolites at 50 ng/ml, Morphine and its metabolites at 300 ng/ml, Methamphetamine at 1000 ng/ml and Phencyclidine at 25 ng/ml.

- C. Reproducibility studies for Cocaine, Cannabinoids, Morphine, Precision: Methamphetamine and PCP indicate:

| Within run and run to run | > 99 % |
|---------------------------|--------|
| Within day and day to day | > 99 % |
| Within lot and lot to lot | > 99 % |

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| 8. Attachments:<br>Correlation Studies | (Accuracy) | Section A |
|-----------------------------------------------|---------------------------------------------------------------------------------|-----------|
| Specificity Studies | (Interference substances and cutoff levels of<br>Each individual Drug of Abuse) | Section B |
| Sensitivity Studies | (Analytical studies) | Section C |
| Reproducibility Studies | (Precision) | Section D |
| Visualine® V Dipstrip Panel<br>Package Insert | | Section E |
| DRI Inserts for Hitachi 717 | | Section F |
| Label Copies | | Section G |
| Stability Studies | | Section H |

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:

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized image of an eagle with three human profiles incorporated into the design of the eagle's neck and head. The eagle is facing to the left.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 7 1999

Ming Sun, Ph.D. President Sun Biomedical Laboratories, Inc. 604 VPR Center 1001 Lower Landing Road Blackwood, New Jersey 08012

Re: K993485

> Trade Name: Visualine@ V Drugs of Abuse Dipstrip Panel Regulatory Class: II Product Code: DIO, LDJ, DJG, DKZ, LCM Dated: October 11. 1999 Received: October 14, 1999

Dear Dr. Sun:

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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#### Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 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 Putman

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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Page__________________________________________________________________________________________________________________________________________________________________________

K 993485 S10(k) Number (if known): _

Visualine V Drugs of Abuse Dipstrip Panel crice Name:_

Indications For Use:

Simultaneous qualitative visual tests for five (5) drugs of abuse: Cocaine, Morphine, Cannabinoids, Methamphetamine and Phencyclidine and their metabolites in urine sample.

Den Cooper
(Division Sign-Off)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993485

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Concurrence of CDRH. Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

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Over-The-Counter Use_

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