VISUALINE METHADONE DIPSTRIPTEST

K023856 · Sun Biomedical Laboratories, Inc. · DJR · Aug 25, 2003 · Clinical Toxicology

Device Facts

• Record ID: K023856
• Device Name: VISUALINE METHADONE DIPSTRIPTEST
• Applicant: Sun Biomedical Laboratories, Inc.
• Product Code: DJR · Clinical Toxicology
• Decision Date: Aug 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

The Visualine® Methadone DipStrip Test is used for qualitative testing for the presence of Methadone in human urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.

Device Story

Visualine® Methadone DipStrip Test is an in-vitro immunochromatographic assay for qualitative detection of Methadone in human urine. Device utilizes competitive binding principle; urine sample applied to porous membrane; drug/metabolites compete with drug-labeled microspheres for limited antibody binding sites. Absence of drug allows microspheres to bind, forming visible magenta line; presence of drug inhibits binding, preventing line formation. Control line confirms test viability. Used by medical professionals in clinical settings for preliminary screening. Results interpreted visually by clinician; positive screening results require confirmation via more specific alternative method (e.g., GC/MS). Benefits include rapid (5-minute) point-of-care identification of Methadone presence to inform clinical decision-making.

Clinical Evidence

Bench testing only. Study compared 132 urine samples (56 positive, 76 negative) against Hitachi EMIT II and GC/MS. Results showed 100% agreement with predicate. Comparison with GC/MS showed 98.2% agreement for positives and 100% for negatives. Precision >99% across lots, days, and runs. Analytical sensitivity established at 300 ng/mL cutoff.

Technological Characteristics

Porous membrane dipstrip; microspheres coated with rabbit polyclonal methadone antibody; goat-anti-rabbit IgG control line; drug-BSA conjugate test line. Competitive binding immunoassay principle. Visual readout. Storage 2-30°C. No ancillary equipment required.

Indications for Use

Indicated for qualitative screening of Methadone in human urine at or above 300 ng/ml. Intended for use by medical professionals in laboratory settings. Not for point-of-care use.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

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

Submission Summary (Full Text)

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K023856

## AUG 2 5 2003

#### 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® Methadone DipStripTest

#### 3. Common Name:

An in-vitro immunoassay test by visual color comparison for the detection of Methadone and it's metabolites in human urine samples. This test is intended for professional use only.

#### 4. Regulation # and Classification:

Reg. #862-3620, Class II Device

#### 5. Test Description:

The Visualine® Methadone DipStripTest is based on the principle of antigen-antibody complexation and is used for the analysis of Methadone and it's metabolites in urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered in a sample well on the device that holds the porous membrane. When the drug is present in the urine test sample, the drug or drug metabolite competes 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.

A reference or control line with a secondary antibody reaction is added to the membrane strip to indicate viability of the test. This control line should always be present. A negative urine sample will produce two colored lines and a positive urine sample will show only one, the control line.

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

Emit The Visualine® Methadone DipStrip Test assay is correlated to the Hitachi The following table illustrates the similarities and differences Methadone Assay. between the two assays.

| | Hitachi® Methadone Assay | Visualine® Methadone DipStrip<br>Test |
|---------------------|-----------------------------------------------------------------------|---------------------------------------|
| Test Principle | Homogenous enzyme<br>immunoassay | Competitive binding<br>immunoassay |
| Sample/Sample Size | 200 uL urine | Approx. 150 uL (3 drops) urine |
| Antibody | Polyclonal | Polyclonal |
| Tracer | Drug-Glucose-6-Phosphate<br>Dehydrogenase | Ab Colloidal Complex |
| Detection Method | Change in absorbance (ΔΑ)<br>value detected<br>spectrophotometrically | Visual color<br>precipitin formation |
| Test Run Time | 10-20 minutes, dependent on test | 5 minutes |
| Storage Requirement | 2-8℃ (36-46ºF) | 2-30℃ (36-86°F) |
| Detection Level | 300 ng/ml Methadone | 300 ng/ml Methadone |
| Ancillary Equipment | Hitachi Emit Calibrators | none |

- 7. Visualine® Methadone DipStrip Test Performance Characteristics
- A. Correlation studies between Hitachi Methadone Assay and

Visualine® Methadone DipStrip Test were conducted at Sun Biomedical Laboratories with samples provided by The Lab, Inc. Correlation with Hitachi EmitII® Methadone Assay with cutoff at or above 300 ng/ml Methadone yielded the following data:

| Analytical Sensitivity | 56 / 56 | = >99% Agreement |
|------------------------|-----------|------------------|
| Analytical Specificity | 76 / 76 | = >99% Agreement |
| Analytical Efficiency | 132 / 132 | = >99% Agreement |

- B. Analytical Specificity and Substances Detected: The test is specific to Methadone or structurally related compounds. The test detects Methadone at a concentration of 300 ng/ml.
- C. Visualine® Methadone DipStrip Test Analytical Sensitivity: The analytical sensitivity at 360 ng/ml Methadone read at 5 minutes is >99%.
- D. Precision: Reproducibility studies indicate:

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

- E. Analytical Studies versus precision and accuracy studies: The Visualine® Methadone DipStrip Tests detect methadone at a cutoff of 300 ng/ml.
1131103

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#### F. Stability Statement:

Visualine® Methadone DipStrip Test stability has been studied. The drug urine tests are tested every three months and reviewed for acceptance by the Quality Control Manager for up to a period of over two years. The acceptance criteria are as follows: A urine specimen containing 0 ng/ml of the analyte of interest will always render two distinct visible magenta lines, one test line and one control line. Samples containing 360 ng/ml of methadone show positive results >99% of the time, (yielding only the control line). Visulaine® Methadone DipStrip Test Kits are stable within their marked expiration date and under the storage conditions as described in the package insert.

page 8 Amended 4/03

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the perimeter of the circle. The logo is black and white.

AUG 2 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Mary Ann Bompadre Regulatory Manager Sun Biomedical Laboratories Inc. 604 VPR Center 1001 Lower Landing Road Blackwood, NJ 08012

Re: k023856

Trade/Device Name: Visualine® Methadone DipStrip Test Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: June 6, 2003 Received: July 22, 2003

Dear Ms. Bompadre:

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) 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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 [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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo and address of Sun Biomedical Laboratories, Inc. The logo consists of a black circle with a white shape inside, followed by the company name in bold, uppercase letters. Below a horizontal line, the address is listed as 604 VPR Center, 1001 Lower Landing Rd, Blackwood, NJ, USA 08012.

**www.sunbiomed.com**

Tel: [phone]

Fax: [phone]

# 510 (k) Number: K 03385 6

# DEVICE NAME: Visualine® Methadone DipStrip Test

INDICATIONS FOR USE: The Visualine® Methadone DipStrip Test is used for qualitative testing for the presence of Methadone in human urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.

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)

A. Ueberlinz

Division Sian-Off Division of Clinical Laboratory D 510(k) Number